MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.0/2.5MM DRIVER BIT; HTW- BIT, DRILL

Catalog Number	231220211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in japan.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the driver tip fractured during the procedure while attempting to remove a plating system while following the correct surgical technique.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6 the reported is confirmed through returned product analysis.Visual examination of two returned products identified both drivers show signs of use.The proximal end of both drivers shows signs of wear and tear.The distal end of one drivers is fractured and not all pieces were returned.The distal end of the other driver is damaged.Measured both drivers, sample 2 is conforming to the print.The overall length of sample 1 is out of tolerance due to the fracture on the distal end of the driver.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2.The reported event is confirmed through evaluation of the returned device.Visual examination of two returned products identified both drivers show signs of use.The proximal end of both drivers shows signs of wear and tear.The distal end of one drivers is fractured and not all pieces were returned.The distal end of the other driver is damaged.Measured both drivers, sample 2 is conforming to the print.The overall length of sample 1 is out of tolerance due to the fracture on the distal end of the driver.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to use error.The plates attempting to be explanted are from the alps elbow fracture plating system.Per the associated surgical technique, the 2.5 mm locking and non-locking screws are indicated to be implanted, and therefore also removed, with the 1.3 mm square driver from the alps elbow instrument tray, which is part 231218012.As the screws were implanted with alps elbow plates and attempted to be removed with driver part 231220211, the use of this driver is off label.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 is available at the time of this report.

• Brand Name: 2.0/2.5MM DRIVER BIT
• Common Device Name: HTW- BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23660930
• Report Number: 0001825034-2025-03813
• Device Sequence Number: 18714228
• Product Code: HTW
• UDI-Device Identifier: 00887868444913
• UDI-Public: (01)00887868444913(11)240221(10)910411
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 231220211
• Device Lot Number: 910411
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 03/30/2026; 04/28/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 04/27/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Patient Sex: Unknown