MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRIVER FOR LOCKING SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5881-26
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision knee procedure, the hex driver fractured while attempting to decouple the knee prosthesis.The procedure was unable to be completed at that time.Due diligence is complete as multiple attempts were made; however, no further information or product has been received.
Additional Manufacturer Narrative
(b)(4).Report foreign source: germany.Visual and dimensional evaluations could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
Additional information provided does not alter previously reported investigation results.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
Additional information provided does not alter previously reported investigation results.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post implantation, the patient was scheduled for a debridement procedure with an articular surface exchange.During the surgery, the hex driver fractured while attempting to decouple the knee prosthesis.The surgeon therefore modified the surgical procedure as the articular surface was unable to be exchanged as planned.The patient is not scheduled for another surgery at this time.It was reported that no further information is available.

• Brand Name: DRIVER FOR LOCKING SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 15314666
• Report Number: 0001822565-2022-02470
• Device Sequence Number: 6484734
• Product Code: LXH
• UDI-Device Identifier: 00889024199958
• UDI-Public: (01)00889024199958(10)64525774
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2022

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: 5881-26
• Device Catalogue Number: 00588102600
• Device Lot Number: 64525774
• Was Device Available for Evaluation?: No
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 08/16/2022; 09/29/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/12/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 86 KG