MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN 0 DEG KEL TIB PEG DRL; INSTRUMENT, KNEE

Catalog Number	42539901831
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of a drill bit fractured off and remains in the patient¿s tibia.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).H3- customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Proposed annex g code: mechanical (g04) ¿ drill.
Event or Problem Description
No further event information is 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: b4, b5, d4, d9, g3, h2, h3, h6.The following section was corrected: h4.Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified signs of repeated use in the form of wear marks on the shaft above the flutes and the tip of the device is fractured.The device was submitted for further analysis.Analysis determined the device fracture surface exhibit river lines and hinge artifacts suggesting that the device possibly fractured due to either torsional or bending overload.The device history record was reviewed and no discrepancies relevant to the reported event were found.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: PSN 0 DEG KEL TIB PEG DRL
• 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: 22839382
• Report Number: 0001822565-2025-02997
• Device Sequence Number: 9250816
• Product Code: JWH
• UDI-Device Identifier: 00889024632455
• UDI-Public: (01)00889024632455(11)230313(10)65670807
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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 Catalogue Number: 42539901831
• Device Lot Number: 65670807
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown