PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLA

Description of Event or Problem

DURING A HUMERUS FRACTURE FIXATION SURGERY, A PANTERA SUTURE CLIP BROKE FROM EXCESSIVE MANIPULATION.

Additional Manufacturer Narrative

THIS REPORT WAS MISTAKENLY NOT REPORTED TO THE FDA AND IS NOW BEING SUBMITTED IN RESPONSE TO AN FDA INSPECTION 483 ITEM. THE (B)(4) SALES DISTRIBUTOR, INITIALLY REPORTED THE INCIDENT TO THE (B)(4) MEDICAL DIRECTOR ON THE DATE NOTED ABOVE. AN INVESTIGATION WAS PERFORMED BY THE (B)(4) MEDICAL DIRECTOR TO DETERMINE IF THE CORRECT SURGICAL PROCEDURE WAS USED AND THE METHOD OF FAILURE FOR THE SUTURE CLIP. THE SURGEONS CONFIRMED THAT THE PLATE SYSTEM PERFORMED AS INTENDED FOR THE SURGERY, OTHER THAN THE BROKEN SUTURE CLIP, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE MEDICAL DIRECTOR DISCOVERED THAT THE ACTING SURGEON WAS USING A GRADE OF SUTURE WIRE MUCH LARGER THAN THE RECOMMENDED SUTURE (#5 FIBERWIRE), AND WAS ALSO OVER MANIPULATING THE CLIPS DURING THE REDUCTION PROCESS. ONE LEG OF THE SUTURE CLIP BROKE AND THEREFORE THE CLIP BECAME DETACHED FROM THE PLATE. THE (B)(4) MEDICAL DIRECTOR SHARED VALIDATION TEST DATA WITH THE SURGEON, AND ALL PARTIES AGREED THAT #2 ETHIBOND SUTURE WIRE STRENGTH IS MORE THAN ADEQUATE AND SHALL BE USED PER THE (B)(4) PANTERA SYSTEM RECOMMENDATIONS. THE DEVICE MALFUNCTIONS RESULTED IN A MINOR DELAY DURING THE SURGICAL PROCEDURE, BUT OTHERWISE, NO OTHER NEGATIVE IMPACT WAS NOTED DURING THE EVENT.