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Patient 1
DEVICE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT: PART: 03.111.031. LOT: L227486 MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 23. DEC. 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY BACKGROUND: IT WAS REPORTED ON AN UNKNOWN DATE THAT BONE HARVESTING TREPHINE STYLET WAS FOUND BENT WHEN PUTTING UP SET. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) PATIENT. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE BONE HARVESTING TREPHINE STYLET (P/N 03.111.031. LOT L227486). WAS RECEIVED SHOWING THE SHAFT BENT. NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: DRAWING: STYLET TREPHINE ORTHOPEDIC FOOT SE_195176 REV C. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WERE REVIEWED. STYLET TREPHINE ORTHOPEDIC FOOT SE_195176 REV C/D DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE BONE HARVESTING TREPHINE STYLET (P/N 03.111.031 LOT L227486) AS THE SHAFT WAS BENT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED BENDING FORCES. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.