CLAVICLE PLATE 3.5MM

Additional Manufacturer Narrative

WE HAVE INSPECTED THE DHF OF THE AFFECTED PLATE AND THE MATERIAL CERTIFICATE AND THE BATCH WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE ARTICLE MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED FOLLOWING A TECHNICAL INVESTIGATION OF THE DEVICE, A CLINICAL FOLLOW-UP WITH THE OPERATING SURGEON AND AN INDEPENDENT TRAUMA SURGEON REGARDING THE CIRCUMSTANCES OF THE EVENT. ACCORDING TO THE OPERATING SURGEON, THE INCIDENT OCCURRED WHILE THE COMPLIANT PATIENT WAS ASLEEP, WITH NO KNOWN TRAUMA. THE INDEPENDENT TRAUMA SURGEON CONFIRMS PROPER USE AND PROFESSIONAL REDUCTION. A CLEAR RADIOLOGICAL ASSESSMENT OF THE BONE HEALING PROCESS - PARTICULARLY REGARDING DELAYED FRACTURE HEALING - WAS NOT POSSIBLE BASED ON THE AVAILABLE IMAGES. BASED ON THE INFORMATION AVAILABLE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, I.T.S. GMBH OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

Description of Event or Problem

IT WAS REPORTED THAT A CLAVICLE PLATE 10-HOLE BROKE APPROX. 3,5 MONTHS POST-OP.