MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5X140MM DRILL STE; BIT, DRILL

Model Number	8290-29-170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source foreign-(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that alps tibia plate procedure was performed.While drilling, the tip of the drill was fractured and is retained inside the patient's body.The surgeon does not plan to remove the fractured tip.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the flutes on the tip had fractured off.No other damage was identified.Not all fractured pieces were returned.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which 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
No additional 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 corrected: d4 lot number the following sections were updated: b4, b5, d4 (expiration date), d4 (udi#), g3, g6, h1, h2, h4, h10 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: 2.5X140MM DRILL STE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11624573
• Report Number: 0001825034-2021-00849
• Device Sequence Number: 3866302
• Product Code: HTW
• UDI-Device Identifier: 00887868447006
• UDI-Public: (01)00887868447006
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2021

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: 8290-29-170
• Device Catalogue Number: 829029170
• Device Lot Number: 410750
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 06/04/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/26/2021; 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1