Peri-Loc 71161016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010179708), received between Aug 11, 2019 and May 17, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2020Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN ORIF OF LEFT HUMERUS, THE SURGEON PINNED A PLATE TO THE HUMERUS WITH A PERI-LOC K-WIRE TO VERIFY ITS PLACEMENT WITH X-RAY IMAGING. UPON REMOVAL OF THE WIRE, THE TIP OF IT BROKE AND REMAINED INSIDE THE PATIENT. IT IS UNKNOWN WHETHER SURGERY WAS DELAYED OR NOT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 10064201 ↗
• MalfunctionAug 11, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING HAND SURGERY THE DOCTOR NOTICED METAL FRAGMENTS ON THE TIP OF THE NEEDLE WHILE DRILLING. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881920 ↗