NA 03.108.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982071569), received between Jul 18, 2017 and Jan 7, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE GRUB SCREW THAT HOLDS THE ITEM TOGETHER FAILED. THIS IS A MULTI PART ITEM THAT IS DISASSEMBLED FOR CLEANING. DUE TO THIS FAILURE, THAT ITEM CANNOT BE REASSEMBLED AND CANNOT BE USED. THERE IS NO PATIENT DETAIL FOR THE PRODUCT AS THESE ITEMS HAVE BEEN FLAGGED BY STAFF OUTSIDE OF CASES. THERE WAS NO PATIENT HARM REPORTED AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994050 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT LOCKING MECHANISM BROKE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695205 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501206 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501205 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PRODUCT WAS DELIVERED TO THE HOSPITAL FOR THE SURGERY ON (B)(6) 2025. DURING INSTRUMENT CHECK BEFORE SURGERY, A K-WIRE WAS NOT ABLE TO BE PASSED THROUGH THE HOLE FOR A K-WIRE ON THE PRODUCT IN QUESTION. SINCE THERE WAS TIME BEFORE THE SURGERY, THE SALES REP ARRANGED FOR A NEW ONE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237166 ↗
• MalfunctionOct 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, A GUIDE WAS FAILING. THE ADJUSTABLE ANGLE GUIDE WOULD NOT LOCK INTO PLACE AND THERE IS REPORTED FAILURE OF THE MECHANISM THE OPERATION WAS COMPLETED AS PLANNED WITH NO DELAY OR HARM TO THE PATIENT. THIS REPORT IS FOR A POSITIONING DEVICE FOR GUIDING BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003019 ↗
• MalfunctionMay 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT ONE OF THE HOLES IN THE GUIDE DID NOT ALLOW THE PASSAGE OF THE NEEDLE INDICATED FOR THE PROCEDURE WHILE THE SYSTEM LOCKING SCREW WAS ROLLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465484 ↗
• MalfunctionApr 15, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE POSITIONING DEVICE BROKE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A POSITIONING DEVICE FOR GUIDING BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120748 ↗
• MalfunctionMar 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE RESTOCKING A TRAY IN STERILE PROCESSING ON AN UNKNOWN DAY, THE SURGEON NOTICED THAT THE BALL BEARING IN THE POSITIONING DEVICE WAS NOT WORKING PROPERLY AND DID NOT ALLOW THE GUIDE BLOCK TO SLIDE BACK EASILY OVER THE POSITIONING DEVICE. THIS REPORT IS FOR A POSITIONING DEVICE FOR GUIDING BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13829788 ↗
• MalfunctionDec 18, 2019Break; Component Misassembled; Break; Component Misassembled

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING PROXIMAL FEMORAL OSTEOTOMY TO TREAT VARISATION OSTEOTOMY THE POSITIONING DEVICE FOR GUIDING BLOCK INSTRUMENT IN THE LOAN KIT WAS DAMAGED. IT HAD BEEN REASSEMBLED INCORRECTLY AND COULD NOT BE USED OR CORRECTLY ASSEMBLED. IT CAUSED SIGNIFICANT DISRUPTION TO THIS PEDIATRIC CASE AND THE SURGEON HAD TO COMPROMISE HIS INITIAL SURGICAL PLAN. NO BACK UP DEVICE WAS AVAILABLE. THERE WAS SURGICAL DELAY OF AROUND 20-30 MINUTES. PROCEDURE WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) POSITIONING DEVICE FOR GUIDING BLOCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491738 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS DISCOVERED THAT THE POSITIONING DEVICE FOR GUIDING BLOCK WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.  THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8843054 ↗
• MalfunctionSep 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING CHECKING OF THE FUNCTION OF THE POSITIONING DEVICE FOR GUIDING BLOCK ON (B)(6) 2018, IT WAS NOTICED THAT THE LOCKING DEVICE WAS STUCK AND NOT SECURING THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: GUIDE BLOCK (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) . THIS REPORT IS FOR A POSITIONING DEVICE FOR GUIDING BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7903195 ↗
• MalfunctionFeb 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PEDIATRIC HIP OSTEOTOMY PROCEDURE, THE GUIDE BLOCK POSITIONER WOULD NOT SLIDE ONTO THE AIMING/ GUIDING BLOCK CORRECTLY, AND IN TURN, WOULD NOT ALLOW THE GUIDE WIRE TO BE PLACED IN THE PROPER LOCATION. THE NURSE FINALLY HAMMERED THE POSITIONER ONTO THE AIMING BLOCK, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED SURGICAL DELAY, NO FRAGMENTS WERE GENERATED, AND THERE WAS NO REPORTED HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) POSITIONING DEVICE FOR GUIDING BLOCK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7271121 ↗
• MalfunctionJul 18, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT DURING A PROXIMAL FEMUR OSTEOTOMY SURGERY PERFORMED ON (B)(6) 2017, THE POSITIONING DEVICE FOR THE GUIDING BLOCK WOULD NOT LOCK INTO PLACE. EVERY TIME THE SURGEON ATTEMPTED TO LOCK THE BLOCK INTO PLACE IT WOULD MOVE, CAUSING THE GUIDE WIRE NOT TO BE POSITIONED PROPERLY. THE DEVICE WAS ABLE TO BE USED, BUT BECAUSE OF IT NOT LOCKING IN PLACE PROPERLY, IT COMPLICATED THE PROCEDURE CAUSING A ONE (1) HOUR DELAY IN SURGERY. THERE WERE MULTIPLE X-RAYS TAKEN TO ENSURE THAT THE GUIDE WIRE WAS IN THE CORRECT POSITION. THE X-RAYS ARE NOT AVAILABLE. THE SURGERY WAS EVENTUALLY COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. PATIENT IS REPORTED AS BEING IN STABLE CONDITION. CONCOMITANT MEDICAL DEVICES GUIDE WIRE (PART # UNKNOWN, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) POSITIONING DEVICE FOR GUIDING BLOCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6721442 ↗