BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 10634555 · Received October 6, 2020

    Report

    Report Number
    8030965-2020-07730
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    September 9, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    UDI-DI
    07611819028135
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. H3, H6: PART NUMBER: 399.99, LOT NUMBER: T173686, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 07-NOV-2018. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. VISUAL INSPECTION: THE REDUC-FORCEPS WAS RECEIVED WITH ONE JAW BROKEN OFF. THERE WERE LIGHT SCRATCHES ALONG ITS BODY CONSISTENT WITH NORMAL WEAR. NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: COULD NOT BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE RETURNED REDUC-FORCEPS WAS MANUFACTURED IN NOVEMBER 2018 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES NOTED. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 1.4021 STAINLESS STEEL (HARDENED AND TEMPERED) THE CORRECT MATERIAL WAS USED, AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION. SUMMARY THE COMPLAINT CONDITION IS CONFIRMED AS ONE OF THE SERRATED JAWS IS BROKEN OFF. THIS PRODUCTION LOT (T173686) WAS MANUFACTURED IN NOVEMBER 2018 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA. BASED ON THE PROVIDED (LIMITED) INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. HOWEVER, THE DAMAGE APPEARS TO BE THE RESULT OF UNINTENDED FORCES DURING USE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS WERE FLAGGED AS BROKEN AT STERILIZATION, FOLLOWING SURGERY. THIS REPORT IS FOR A REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102847 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD SYNTHES GMBH T173686 07611819028135

    Patients

    Seq Age Sex Outcome Treatment
    1 FIX-SLEEVE F/STEPPED REAMER| HAND-REAMER F/MEDULL-CANAL Ø8| FIX-SLEEVE F/STEPPED REAMER| HAND-REAMER F/MEDULL-CANAL Ø8