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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: japan.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that during initial surgery for alps mtp plate that while inserting the screw, the screwdriver tip broke off and remained inside the screw head.The surgeon gave up on removing the broken fragment and finished the surgery.There was no reported harm, injury or delay.Due diligence is complete.No additional information is available.Status.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Visual examination of the returned product/provided pictures identified the driver bit shows signs of use with the connecting end of the bit having some gouges and the tip of the bit has some positive material and rounded edges.The tip of the driver bit has fractured off and was not returned.The fracture surface showed regions consisting of sheared ductile overload dimples in different parts of the driver bit, suggesting a torsional overload failure.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed by returned device.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 additional information is available regarding the incident.

• Brand Name: 2.0/2.5MM DRIVER BIT
• Common Device Name: 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: 19886622
• Report Number: 0001825034-2024-01961
• Device Sequence Number: 15360476
• Product Code: HTW
• UDI-Device Identifier: 00887868027086
• UDI-Public: (01)00887868027086(11)181002(10)584001
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: N/A
• Device Catalogue Number: 231220211
• Device Lot Number: 584001
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2018
• 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: Prefer Not To Disclose