MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION 3.5MM HEX DRIVER; INSTRUMENT, KNEE

Catalog Number	42583005700
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: (b)(6).Visual examination of the returned product identified signs of use and confirming that the tip is fractured, not all pieces were returned.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Optical images of the device fracture surface exhibit two angular planes indicating a two step fracture, and both fracture planes show river line artifacts suggesting that the device possibly fractured due to bending overload with a torsional stress component.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.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 during an initial knee procedure, the hex driver became worn out and was found to be fractured.There was no patient impact and no adverse events have been reported as a result of the malfunction.Another driver was used to complete the procedure without further incident.All available information has been provided.

• Brand Name: PERSONA REVISION 3.5MM HEX DRIVER
• 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: 24629418
• Report Number: 0001822565-2026-00826
• Device Sequence Number: 8596902
• Product Code: HXX
• UDI-Device Identifier: 00889024563162
• UDI-Public: (01)00889024563162(10)67123688
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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 Catalogue Number: 42583005700
• Device Lot Number: 67123688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown