S-ROM 53-4151Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295171744), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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.

• InjuryNov 1, 2019Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHAFT PILOT (P/N: 534151) WAS COME OFF WHEN USING A CONE REAMER BECAUSE THE MODE SWITCH HAD BEEN SET TO REVERSE ROTATION DURING THE THA SURGERY ON (B)(6) 2019, AND THE SHAFT PILOT WAS REMAINED IN MEDULLARY CAVITY. ALTHOUGH THE SURGEON ATTEMPTED TO REMOVE THE SHAFT PILOT FROM MEDULLARY CAVITY, IT COULD NOT. THUS, THE SURGEON MADE ANOTHER INCISION ON THE KNEE, PUT K-WIRE INTO THE INCISION, PUSHED THE SHAFT PILOT FROM DISTAL SIDE, AND REMOVED IT FROM PROXIMAL SIDE. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 9267737 ↗