NA 208.441Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982149466), received between Apr 26, 2017 and Oct 5, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K021932, K161616); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS REMOVAL OF CANNULATED SCREWS TO CONVERT TO TOTAL HIP DUE TO NONUNION. UNKNOWN SCREW SIZES. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR A 6.5MM CANNULATED SCREW 32MM THREAD 95MM.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15542724 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS REMOVAL OF CANNULATED SCREWS TO CONVERT TO TOTAL HIP DUE TO NONUNION. UNKNOWN SCREW SIZES. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR A 6.5MM CANNULATED SCREW 32MM THREAD 95MM.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15542673 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS REMOVAL OF CANNULATED SCREWS TO CONVERT TO TOTAL HIP DUE TO NONUNION. UNKNOWN SCREW SIZES. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR A 6.5MM CANNULATED SCREW 32MM THREAD 95MM.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15542623 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREE (3) CANNULATED SCREWS WERE REMOVED FROM THE PATIENT'S SACROILIAC JOINT DUE TO PAIN. THERE WAS NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 6.5MM CANNULATED SCREW 32MM THREAD 95MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11454701 ↗
• InjuryJan 9, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED A REVISION OF HIP PINNING WAS CONDUCTED ON (B)(6) 2017 AFTER THE PATIENT WAS IMPLANTED ON (B)(6) 2017. THE PATIENT WAS REVISED TO A 4.5MM PROXIMAL FEMUR PLATE. FIVE 6.5MM PARTIALLY (32MM) THREADED CANNULATED SCREWS (80, 90, 95, 100, 110MM) AND FOUR WASHERS WERE REMOVED FROM THE PATIENT; ONE WASHER WAS LEFT IN PATIENT. REMOVAL OF HARDWARE WAS QUICK AND EASY. THE SCREWS WERE REPLACED WITH A PROXIMAL FEMUR PLATE AS THE SCREW FIXATION FAILED. THE SURGEON WAS UNABLE TO RETRIEVE THE WASHER IMPLANTED IN THE PATIENT BECAUSE SHE PLATED OVER THE SCREW. ORIGINALLY, SHE WAS GOING TO LEAVE IT IN, BUT THEN DECIDED TO TRY AND TAKE OUT THE SCREW AND THE WASHER AFTER PLATING. THE SCREW WAS ABLE TO BE RETRIEVED, BUT NOT THE WASHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTEDLY STABLE. CONCOMITANT DEVICES: WASHER (PART 219.99, LOT UNKNOWN, QUANTITY 5) . THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7175485 ↗
• MalfunctionApr 26, 2017Peeled/Delaminated; Peeled/Delaminated

  CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES; THIS REPORT IS AGAINST (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. IT WAS REPORTED THAT A PATIENT HAD AN ELECTIVE REMOVAL OF BILATERAL DEEP HIP IMPLANTS ON (B)(6) 2016. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2016 IN WHICH A PERIACETABULAR OSTEOTOMY WITH SURGICAL HIP DISLOCATION AND GREATER TROCHANTERIC OSTEOTOMY WAS PERFORMED FOR BILATERAL SLIPPED CAPITAL FEMORAL EPIPHYSIS. DURING THE REMOVAL PROCEDURE THE SURGEON WAS UNABLE TO REMOVE THE 6.5 MM CANNULATED SCREW ON THE RIGHT HIP DUE TO THE SCREW BEING STRIPPED; BONY GROWTH WAS NOTED AROUND THE SCREW HEAD. THE SURGEON USED A REVERSE CUTTING SCREW REMOVAL, THEN THE SCREWDRIVER BROKE AND THE TIP OF THE SCREWDRIVER WAS CONFIRMED VIA FLUOROSCOPY TO REMAIN IN THE HEAD OF THE SCREW AND NOT FREE IN THE MUSCLE MASS. THE SURGEON REVIEWED THE OPTIONS WITH THE PATIENT¿S MOTHER AND THEY ELECTED TO NOT ATTEMPT FURTHER REMOVAL OF THE SCREW. DURING THE REMOVAL ON THE LEFT HIP, TWO SCREWS WERE EASILY AND SUCCESSFULLY REMOVED WITHOUT COMPLICATIONS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT WAS W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6522521 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021932, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-2154-2016 · Feb 16, 2016 · Terminated
  7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bo
• Z-2157-2016 · Feb 16, 2016 · Terminated
  4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large b
• Z-2152-2016 · Feb 16, 2016 · Terminated
  6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragment
• Z-2155-2016 · Feb 16, 2016 · Terminated
  4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone
• Z-2153-2016 · Feb 16, 2016 · Terminated
  6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragment
• Z-2156-2016 · Feb 16, 2016 · Terminated
  4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, s
• Z-2158-2016 · Feb 16, 2016 · Terminated
  3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bo