FDA Adverse Event Malfunction Summary report: N

SYMMETRY RETRACTOR, HOHMANN, 18 MM WIDE, 9.5 IN

MDR report key: 21035339 · Received December 30, 2024

Report

Report Number: 3007208013-2024-00063
Event Type: Malfunction
Date Received: December 30, 2024
Report Date: December 30, 2024
Manufacturer: SYMMETRY SURGICAL INC.
Product Code: GAD
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

PICTURES WERE PROVIDED FOR REVIEW AND THE DEVICE WAS RETURNED FOR EVALUATION AS WELL. UPON REVIEW, IT IS OBVIOUS THAT THE TIP OF THE INSTRUMENT FRACTURED OVER TIME AND USE. THE INSTRUMENT WAS PURCHASED IN 2015-2016 TIMELINE. LOOKING AT THE STRIATIONS IN THE STAINLESS STEEL THERE ARE MULTIPLE BREAKS IN THE STEEL INCLUDING AN UP/DOWN SNAP. AS WELL AS THE POLISHED 45 DEGREE ANGLED FRACTURE OF THE STAINLESS STEEL. THERE IS A STEP IN THE BREAK OF THE STAINLESS STEEL INDICATIVE OF THE INSTRUMENT BEING USED IN A PRYING APPLICATION. THE SIDE PICTURES SHOW A GOUGED ROLLED STAINLESS STEEL EDGE FROM SIGNIFICANT MISUSE OVER TIME. THE ROOT CAUSE WAS USER ERROR AS WELL AS WEAR AND TEAR DUE TO A LONG DURATION OF MISUSE. NOTE THAT WE HAVE REACHED OUT FOR ADDITIONAL INFORMATION NUMEROUS TIMES, AND WE STILL HAVE LIMITED INFORMATION REGARDING THE DETAILS OF THE PROCEDURE AND THE PATIENT INTERACTION. THIS SHOULD BE CONSIDERED THE FINAL REPORT, HOWEVER IF ADDTIONAL RELEVANT DETAILS ARE IDENTIFIED THEY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 0

COMPLAINANT ALLEGES "WE WANTED TO REPORT THAT WE HAD A TIP BREAK OFF OF A RETRACTOR #77-1118 WHILE IN USE IN A CASE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2437006	SYMMETRY RETRACTOR, HOHMANN, 18 MM WIDE, 9.5 IN	RETRACTOR	GAD	SYMMETRY SURGICAL INC.	77-1118	1511314

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown