BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS

    MDR report key: 8654665 · Received May 30, 2019

    Report

    Report Number
    2939274-2019-58383
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    April 29, 2019
    Report Date
    April 30, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982072573
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY LOT PART: 03.111.751. LOT: 515738. MANUFACTURING SITE: SELZACH. SUPPLIER: GSELL MEDICAL PLASTICS AG. RELEASE TO WAREHOUSE DATE: 19. MAR. 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. COMPLAINT SUMMARY: IT WAS REPORTED THAT ON APRIL 29, 2016, DURING DISTAL RADIUS FRACTURE SURGERY, THE ONE (1) SOFT TISSUE ATTACHMENT FOR REDUCTION FORCEPS WAS BEING ATTACHED AND THE PIECE ACTUALLY BROKE THE PLASTIC ENDS WHERE IT ATTACHES TO THE CLAMP. HE WAS HAVING DIFFICULTY ATTACHING PIECE AND USED MORE FORCE THAN GENERALLY ACQUIRED, RESULTING IN ATTACHMENT PORT TO BREAK AND GENERATE ONE ADDITIONAL FRAGMENT. NO FRAGMENTS WERE GENERATED AROUND PT OR OPENING INCISION. THERE WAS A MINUTE (1) SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED WITHOUT USING THE CLAMP. PATIENT OUTCOME COMPLETED. FLOW: DAMAGE . VISUAL INSPECTION: THE INSTRUMENT WAS RECEIVED AT US CQ WITH THE KNOB FEATURE OF THE RETURNED PLASTIC DEVICE (PPSU LSG BLACK) HAS BROKEN. THE FRACTURE AREA SHOWS EVIDENCE OF DEFORMING PRIOR TO BREAKING. THE BROKEN OFF PIECE WAS NOT RETURNED. THE BALANCE OF THE RETURNED DEVICE IS IN FAIR CONDITION SHOWING SOME SIGNS OF WEAR. A DEVICE FAILURE WAS IDENTIFIED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION OF FEATURES RELEVANT TO THIS COMPLAINT COULD NOT BE OBTAINED AT CQ DUE TO POST MANUFACTURING DAMAGE. DOCUMENT SPECIFICATION. THE FOLLOWING DOCUMENTS WERE REVIEWED AS PART OF THIS INVESTIGATION: SOFT TISSUE ATTACHMENT J-SHAPED FOR REDUCTION: SE_461828 REV C. REVIEW OF THE MANUFACTURING RECORD EVALUATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION CONCLUSION: THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED IT IS POSSIBLE THAT ROUGH HANDLING DURING SURGERY HAS LED TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT ID: (B)(6). THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT DISTAL RADIUS FRACTURE SURGERY. DURING THE SURGERY, THE ONE (1) SOFT TISSUE ATTACHMENT FOR REDUCTION FORCEPS WAS BEING ATTACHED AND THE PIECE BROKE THE PLASTIC ENDS WHERE IT ATTACHES TO THE CLAMP. SURGEON WAS HAVING DIFFICULTY ATTACHING PIECE AND USED MORE FORCE THAN GENERALLY ACQUIRED, RESULTING IN ATTACHMENT PORT TO BREAK AND GENERATE ONE ADDITIONAL FRAGMENT. NO FRAGMENTS WERE GENERATED AROUND PT OR OPENING INCISION. THERE WAS A ONE (1) MINUTE SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED WITHOUT USING THE CLAMP. PATIENT OUTCOME WAS OKAY. CONCOMITANT DEVICE: REDUCTION CLAMP (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTACHMENT FOR REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450031 SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.111.751 515738 10886982072573

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR UNK - REDUCTION CLAMP| UNK - REDUCTION CLAMP