NA 208.414Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982149213), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DOING PERCUTANEOUS PINNING OF THE HIP FRACTURE USING WITH THE 6.5 MM CANNULATED SCREWS, IT APPEARED THAT THE PRODUCT HAD A MANUFACTURING DEFECT. THE SCREWDRIVER RECESS ON THE CANNULATED SCREW WOULD NOT BE CENTER; THEREFORE, THE SCREWDRIVER WOULD NOT FIT INTO THE SCREW AND THE SCREW SLIPPED OVER WITH THE GUIDEWIRE. UPON PUTTING A 95MM SCREW OVER THE GUIDE WIRE, THE SCREWDRIVER WOULD NOT PROPERLY SIT IN THE RECESS OF THE SCREW HEAD. IT WAS DETERMINED VISUALLY THAT THE CANNULATION WAS OFF-CENTER IN THE RECESS OF THE SCREW HEAD WHICH PREVENTED THE SCREWDRIVER FROM SEATING INTO THE SCREW ONCE THE SCREW IS PLACED OVER A GUIDE WIRE THERE WAS A SURGICAL DELAY OF FOUR (4) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT HAD A GOOD/POSITIVE PATIENT OUTCOME. THIS REPORT INVOLVES ONE (1) 6.5MM CANNULATED SCREW 16MM THREAD 95MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454075 ↗

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-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-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-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-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
• 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-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