MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH TWO-FLUTED DRILL BIT 2.5 MM, WITH QUICK COUPLING, L. 154/180 MM; TRAUMA INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the drill fractured inside the patient¿s bone.The piece could not be removed and remained inside the patient.Unknown impact or consequence to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Source foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The complained product was returned for examination and the reported event can be confirmed.A large portion of the drill bit has fractured off.Review of the device history records identified no deviations or anomalies during manufacturing.The raw material certificate was reviewed with no anomalies noted.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Device is used for treatment.Medical records were not provided.Although the instrument is a reusable instrument, the number of instrument usage is unknown.It is likely that a high application of force or a bad drilling angle caused or contributed to the reported event.However, based on the received information and details of the investigation, 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 available at the time of this report.

• Brand Name: TWO-FLUTED DRILL BIT 2.5 MM, WITH QUICK COUPLING, L. 154/180 MM
• Common Device Name: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14926780
• Report Number: 0009613350-2022-00346
• Device Sequence Number: 12313054
• Product Code: HTW
• UDI-Device Identifier: 00889024298064
• UDI-Public: (01)00889024298064(11)130226(10)PF13958
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• 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
• Report Date (Section B): 08/19/2022

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: 10325180
• Device Lot Number: PF13958
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown