NA 03.816.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034730622), received between Jul 18, 2019 and Feb 22, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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.

• MalfunctionFeb 22, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED: A PIECE IS BROKEN OFF AT THE THREAD ON THE INSTRUMENT .NO SURGERY DELAY. THERE IS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) RETRACTOR BODY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419250 ↗
• MalfunctionMay 4, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING TESTING OF A SET AT LOANERS DEPARTMENT, THE RETRACTOR BODY ITEMS COMPONENT PARTS BROKE OFF IN PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) RETRACTOR BODY. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769916 ↗
• MalfunctionOct 30, 2020Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING EVALUATION AT SERVICE, AND REPAIR IT WAS FOUND OUT THAT THE RETRACTOR BODY COMPONENT WAS DAMAGED, IT WON'T STAY ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS NOTICED THAT THE ONE OF THE GENERIC PIN (ZYL_STI_D_X_5.8MM) WAS RECEIVED DISASSEMBLE DUE TO WHICH THE SCREW SLEEVE AND SCREW ANGULATION BLADE ASSEMBLY WAS FELL APART FROM THE LEFT RETRACTOR ARM AND MISSING A CLIP COMPONENT. THE SCREW ANGULATION BLADE WAS OBSERVED TO BE BROKEN AND THE BROKEN FRAGMENTS WERE NOT RETURNED. THIS PRODUCT CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON OCTOBER 23, 2020. THIS REPORT IS FOR ONE (1) RETRACTOR BODY THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10764394 ↗
• MalfunctionSep 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE DEMO ON AN UNKNOWN DATE, THE BLADE HOLDER WAS NOT ENGAGING WITH THE BLADE AND SALES REP WAS UNABLE TO ACTUALLY PUT TOGETHER THE RETRACTOR. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) RETRACTOR BODY. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10480287 ↗
• MalfunctionJul 18, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED ON JUNE 25, 2019, DURING AN INSPECTION OF THE LOANER SET, A RETRACTOR BODY AND A 3RD BLADE HOLDER WERE NOT FUNCTIONING CORRECTLY. THE 3RD BLADE HOLDER WAS DISCOVERED NOT ALLOWING THE BLADE TO BE INSERTED FLUSH. THE ISSUE WAS DISCOVERED DURING AN OVERVIEW BEFORE CHECKING THE SET IN  STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.  THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8805387 ↗