NA 03.100.107Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982071057), received between Jul 30, 2020 and Oct 4, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE IS WORN. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20372913 ↗
• MalfunctionNov 15, 2023Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING INCOMING LOAN KIT INSPECTION, THE TIP OF THE INSTRUMENT IN QUESTION WAS FOUND WITH A HOLE IN IT. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ALUMINUM BLUNT PELVIC RETRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141077 ↗
• MalfunctionDec 6, 2021Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UNABLE TO STERILIZE/ASSEMBLE THE MALLEABLE RETRACTOR. CHIPPING AND CRACKING ON INSTRUMENTS. UNABLE TO USE. THIS COMPLAINT INVOLVES TEN(10) DEVICES. THIS REPORT IS FOR (1) ALUMINUM BLUNT PELVIC RETRACTOR. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12937324 ↗
• MalfunctionJul 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE RADIOLUCENT PELVIC RETRACTOR WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT REPORTED. THIS REPORT IS FOR A PELVIC RETRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151026 ↗
• MalfunctionJul 30, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE HIGH TIBIAL OSTEOTOMY (HTO) SURGERY. DURING THE SURGERY, THE RADIOLUSCENT PELVIC RETRACTOR WAS USED FOR POSTERIOR TISSUE PROTECTION DURING OSTEOTOMY BY HTO. THE RADIOLUSCENT PELVIC RETRACTOR WAS CUT WITH THE BONE WHILE USING AN OSCILLATING SAW, WHICH MANUFACTURED BY A COMPETITOR. THE CUT RADIOLUSCENT PELVIC RETRACTOR WAS NOT FOUND UNDER FLUOROSCOPY, THE SURGEON FOUND IT AFTER RETURNING TO THE INSTRUMENT TABLE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THE SURGEON COMMENTED THAT THERE SHOULD BE NO PROBLEM BECAUSE THE METAL POWDER WAS WASHED ENOUGH SO THAT IT WOULD NOT REMAIN IN THE PATIENT¿S BODY. CONCOMITANT DEVICE REPORTED: OSCILLATING SAW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) ALUMINUM BLUNT PELVIC RETRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10344980 ↗