MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY LAG SCREW INSERTER LONG; TRAUMA INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the revision planned by the customer was impossible to perform.After the locking screw removal, they were unable to remove the head screw from the nail and consequently the nail itself.The screwdriver could not be fixed on the cephalic screw and therefore the screw could not be removed.The surgeon had a good vision of the screw and it had been cleared of any bony elements that could interfere between the screw and the screwdriver.The patient had general anesthesia and had surgery without success, the screw causing her pain could not be removed.The patient went to the surgery room in the morning and was discharged in the early afternoon.At the end of the afternoon, the patient was admitted to the service because of bleeding from the dressing.The bleeding was resolved, and the patient was released the next day.No further information is known.
Additional Manufacturer Narrative
(b)(4).G2: france.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Upon further assessment it was found that there was no issue with this device other that it being worn.The product did not contribute to the reported event.The product will be not reportable as it did not contribute to a serious injury and the malfunction has not contributed to a serious injury in the past.
Additional Manufacturer Narrative
(b)(4).It was discovered that the harm was identified as no harm because this device was not related to the reported event of the shaft not mating to the lag screw.However, it was returned worn.This will now be made not reportable.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CEPHALOMEDULLARY LAG SCREW INSERTER LONG
• Common Device Name: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19807871
• Report Number: 0001822565-2024-02442
• Device Sequence Number: 7497044
• Product Code: HSB
• UDI-Device Identifier: 00889024062818
• UDI-Public: (01)00889024062818(10)64495544
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00249000350
• Device Lot Number: 64495544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG