NA 03.311.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982078032), received between Oct 2, 2018 and Dec 8, 2022 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (25 reports).

2 other recalls cover devices cleared under the same FDA submission (K051600, K092190, K161417); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2022, THAT A SURGEON COMPLAINED THAT OUR 1.8 DRILL TIP WIRES FROM THE MAX-FRAME WERE NOT SHARP ENOUGH. NO ADVERSE EVENTS OCCURRED. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15944980 ↗
• MalfunctionApr 14, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE REDUCTION WIRE WAS FOUND NOT FUNCTIONING DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT . THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959671 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IIT WAS REPORTED THAT ON (B)(6) 2019, DURING A FOOT SURGERY, THE TWO (2) TENSIONERS WOULD NOT RELEASE REDUCTION WIRE DURING THE APPLICATION OF A DISTRACTION OSTEOGENESIS (DO) RING FIXATOR FRAME. IT CAME APART DURING THE ATTEMPTS TO RELEASE THE WIRE FROM THE TENSIONER INTRAOPERATIVELY. THERE ARE TWO TENSIONERS THAT FAILED DURING THE PROCEDURE. ANOTHER ONE (1) TENSIONER COMES TO A HARD STOP WHEN COMPLETELY RELEASING TENSION. IT IS SUPPOSED TO CLICK AND CONTINUE TO ROTATE WHEN ALL TENSION HAS BEEN RELEASED REACHING ITS ENDPOINT HOWEVER, IT DID NOT ¿CLICK¿ WHEN THE HANDLE WAS FULLY OPENED. THE SAME TYPE OF TENSIONER WAS USED TO COMPLETE THE PROCEDURE. NO ISSUE WITH WIRE. TENSIONER¿S FAILED ON BOTH REDUCTION WIRES AND SMOOTH WIRES. RIGHT LOWER EXTREMITY MULTIPLANAR RING EXTERNAL FIXATOR. WIRE DID NOT APPEAR TO BE THE ISSUE. TENSIONER MALFUNCTION OCCURRED ON SEVERAL DIFFERENT WIRES. TWO OF THE TENSIONERS TERMINALLY IMPINGED ON THE WIRE. IN AN EFFORT TO RELEASE THE TENSIONER FROM THE WIRE THE PHYSICIAN CONTINUED TO TURN THE HANDLE COUNTER CLOCKWISE. TWO OF THE TENSIONERS BECAME DISASSEMBLED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238161 ↗
• MalfunctionApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY OPENED THE SIXTEEN (16) REDUCTION WIRE TO BE ADDED TO AN INSTRUMENT SET AND IT WAS NOTICED BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8 MM DIAMETER 400 MM LONG THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8558335 ↗
• MalfunctionApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY OPENED THE SIXTEEN (16) REDUCTION WIRE TO BE ADDED TO AN INSTRUMENT SET AND IT WAS NOTICED BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8558332 ↗
• MalfunctionApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY OPENED THE SIXTEEN (16) REDUCTION WIRE TO BE ADDED TO AN INSTRUMENT SET AND IT WAS NOTICED BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8 MM DIAMETER 400 MM LONG THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8558322 ↗
• MalfunctionApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY OPENED THE SIXTEEN (16) REDUCTION WIRE TO BE ADDED TO AN INSTRUMENT SET AND IT WAS NOTICED BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8558319 ↗
• MalfunctionApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY OPENED THE SIXTEEN (16) REDUCTION WIRE TO BE ADDED TO AN INSTRUMENT SET AND IT WAS NOTICED BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8558309 ↗
• MalfunctionApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY OPENED THE SIXTEEN (16) REDUCTION WIRE TO BE ADDED TO AN INSTRUMENT SET AND IT WAS NOTICED BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8558283 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 9 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8556168 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8 MM DIAMETER 400 MM LONG THIS IS REPORT 10 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8556163 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 1 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8556087 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8 MM DIAMETER 400 MM LONG. THIS IS REPORT 2 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8556082 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8 MM DIAMETER 400 MM LONG. THIS IS REPORT 5 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8555905 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 4 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8555898 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 3 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8555832 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8 MM DIAMETER 400 MM LONG. THIS IS REPORT 7 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8555826 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF SIXTEEN (16) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 6 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8555783 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TOTAL OF (B)(4) REDUCTION WIRES WERE DISCOVERED AS BENT. THIS OCCURRED AFTER OPENING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 8 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8555776 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY ON AN UNKNOWN DATE. IT WAS DISCOVERED THAT FIFTEEN (15) REDUCTION WIRES WERE ALREADY BENT IN A MULTI-AXIAL CORRECTION SYSTEM (MAXFRAME) FOOT CASE. IT WAS STATED THAT UNKNOWN STRAIGHT WIRES WERE USED INSTEAD. THE BENT REDUCTION WIRES WERE NOT USED ON THE PATIENT. PROCEDURE OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TOTAL FIFTEEN (15) DEVICES. DUE TO SYSTEM LIMITATIONS TEN (10) DEVICES ARE CAPTURED UNDER (B)(4) AND REMAINING FIVE (5) DEVICES ARE CAPTURED (B)(4). THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926805 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY OF AN UNKNOWN DATE. IT WAS DISCOVERED THAT FIFTEEN (15) REDUCTION WIRES WERE ALREADY BENT IN A MULTI-AXIAL CORRECTION SYSTEM (MAXFRAME) FOOT CASE. IT WAS STATED THAT UNKNOWN STRAIGHT WIRES WERE USED INSTEAD. THE BENT REDUCTION WIRES WERE NOT USED ON THE PATIENT. PROCEDURE OUTCOME WAS UNKNOWN; NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR A REDUCTION WIRE. THIS IS REPORT 10 OF 10 FOR (B)(4). THE OTHER FIVE REDUCTION WIRES ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926657 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY OF AN UNKNOWN DATE. IT WAS DISCOVERED THAT FIFTEEN (15) REDUCTION WIRES WERE ALREADY BENT IN A MULTI-AXIAL CORRECTION SYSTEM (MAXFRAME) FOOT CASE. IT WAS STATED THAT UNKNOWN STRAIGHT WIRES WERE USED INSTEAD. THE BENT REDUCTION WIRES WERE NOT USED ON THE PATIENT. PROCEDURE OUTCOME WAS UNKNOWN; NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR A REDUCTION WIRE. THIS IS REPORT 9 OF 10 FOR (B)(4). THE OTHER FIVE REDUCTION WIRES ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926617 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY OF AN UNKNOWN DATE. IT WAS DISCOVERED THAT FIFTEEN (15) REDUCTION WIRES WERE ALREADY BENT IN A MULTI-AXIAL CORRECTION SYSTEM (MAXFRAME) FOOT CASE. IT WAS STATED THAT UNKNOWN STRAIGHT WIRES WERE USED INSTEAD. THE BENT REDUCTION WIRES WERE NOT USED ON THE PATIENT. PROCEDURE OUTCOME WAS UNKNOWN; NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR A REDUCTION WIRE. THIS IS REPORT 8 OF 10 FOR (B)(4). THE OTHER FIVE REDUCTION WIRES ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926589 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY ON AN UNKNOWN DATE. IT WAS DISCOVERED THAT FIFTEEN (15) REDUCTION WIRES WERE ALREADY BENT IN A MULTI-AXIAL CORRECTION SYSTEM (MAXFRAME) FOOT CASE. IT WAS STATED THAT UNKNOWN STRAIGHT WIRES WERE USED INSTEAD. THE BENT REDUCTION WIRES WERE NOT USED ON THE PATIENT. PROCEDURE OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TOTAL FIFTEEN (15) DEVICES. DUE TO SYSTEM LIMITATIONS TEN (10) DEVICES ARE CAPTURED UNDER (B)(4) AND REMAINING FIVE (5) DEVICES ARE CAPTURED (B)(4). THIS REPORT IS FOR ONE (1) REDUCTION WIRE/1.8MM DIAMETER 400MM LONG. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926584 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY OF AN UNKNOWN DATE. IT WAS DISCOVERED THAT FIFTEEN (15) REDUCTION WIRES WERE ALREADY BENT IN A MULTI-AXIAL CORRECTION SYSTEM (MAXFRAME) FOOT CASE. IT WAS STATED THAT UNKNOWN STRAIGHT WIRES WERE USED INSTEAD. THE BENT REDUCTION WIRES WERE NOT USED ON THE PATIENT. PROCEDURE OUTCOME WAS UNKNOWN; NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR A REDUCTION WIRE. THIS IS REPORT 7 OF 10 FOR (B)(4). THE OTHER FIVE REDUCTION WIRES ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051600, K092190, K161417. One submission often covers many models, so check the product and lot details in each record.

• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
• Z-1324-2009 · Feb 9, 2009 · Terminated
  Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure componen