SYMMETRY RETRACTOR, HOHMANN, 18 MM WIDE, 9.5 IN
Received Dec 30, 2024
Report 3007208013-2024-00063 · MDR key 21035339
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
COMPLAINANT ALLEGES "WE WANTED TO REPORT THAT WE HAD A TIP BREAK OFF OF A RETRACTOR #77-1118 WHILE IN USE IN A CASE."