MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADED SCREW 48 MM LENGTH; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the head broke off of the screw and it became stuck in the screwdriver.The surgeon had to remove the screw from the femoral cutting jig with another instrument.The surgical technique was utilized.No foreign bodies were retained.There was no surgical delay.The surgery was not completed with another device.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00598304900 - screw inserter/extractor - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4), this follow-up report is being submitted to relay additional and corrected information.Visual inspection of the returned item found the hex feature is fractured off in the hex feature of the screw inserter/extractor.The rest of this screw wasn¿t returned.Review of the device history record and supplier dhr identified no related deviations or anomalies during manufacturing.Medical records were not provided.Root cause cannot be determined for the screw fracture.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: HEADED SCREW 48 MM LENGTH
• Common Device Name: INSTRUMENT, KNEE
• 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: 17498302
• Report Number: 0001822565-2023-02130
• Device Sequence Number: 12360322
• Product Code: LXH
• UDI-Device Identifier: 00889024218277
• UDI-Public: (01)00889024218277(17)330130(10)65633829
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598304048
• Device Lot Number: 65633829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ..
• Patient Sex: Male