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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that during a knee surgery, the surgeon was using the screwdriver with its tip to unscrew the hinge screw from the prosthesis in a counter-clockwise direction.After three-fourths of a turn, the screwdriver jammed and broke off into the hinge screw.It was then not possible to remove the prosthesis without removing the hinge.This resulted in the use of a large number of complimentary boxes leading to a risk of lack of material for the other patients for the day.It also increased operating time by 2 hours.A drill bit was used to remove the hinge.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a right knee revision, the screwdriver broke while trying to remove the hinge pin, resulting in an additional 2 hours to the procedure.No further complications were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: proposed component (annex g) code is mechanical (g04) - drill.Visual examination of the returned product identified signs of repeated use with scratches and a fractured tip.Additional analysis of the product identified river line artifacts suggesting a bending overload mode of fracture.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the screwdriver broke intraoperatively and that the axle was attempted to be removed after breakage.A definitive root cause cannot 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.

• Brand Name: DRIVER FOR LOCKING SCREW
• 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: 17640953
• Report Number: 0001822565-2023-02324
• Device Sequence Number: 12746766
• Product Code: LXH
• UDI-Device Identifier: 00889024199958
• UDI-Public: (01)00889024199958(10)64525774
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023

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: 00588102600
• Device Lot Number: 64525774
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 11/30/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/10/2023; 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• 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
• Patient Sex: Male
• Patient Weight: 90 KG