NA 04.118.530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982108944), received between Oct 2, 2023 and Oct 2, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE SCREW WAS USED TO PULL THE BONE FRAGMENT NEAR WHEN APPLYING AN OLECRANON 4-HOLE PLATE. THE PATIENT¿S BONE QUALITY WAS GOOD, AND IT TOOK TIME TO INSERT THE SCREW, BUT THE SURGEON SUCCEEDED IN INSERTING THE SCREW FULLY. AFTER THAT, THE HEAD PART OF THE SCREW BROKE OFF WHEN THE SURGEON TIGHTENED THE SCREW AT THE END. THE SURGEON DETERMINED THAT IT WOULD BE DIFFICULT TO REMOVE, AND THE SCREW WAS TO REMAIN IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS CONFIRMED BY X-RAYS THAT OTHER THAN THE SHAFT OF THE SCREW REMAINED IN THE BONE, NO BROKEN FRAGMENTS REMAINED IN THE PATIENT¿S BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/30MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17855206 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes