MAUDE Adverse Event Report: ZIMMER BOIMET GMBH SWITZERLAND DRILL BIT WITH QUICK COUPLING, 2-FLUTED, ø 2.5 MM, 154/180 MM; LOWER TRAUMA INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source - foreign: japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that approximately one month and two weeks ago, during the implantation of a distal femur system, the tip of the drill fractured and remained in the bone of the patient.The surgeon was unable to remove the fractured piece.No add issues of the patient were reported.Delay 0-15 minutes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10 product was returned for investigation.Event can be confirmed, as the edge of the drill bit is fracture on the edge.Device was further sent for further analysis to material and research: hardness is according to specification; the fracture surface shows a ductile force fracture.Review of the device history record identified no deviations or anomalies during manufacturing.Device used for treatment.Medical records were not provided.With the available information a definitive root cause cannot be established.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: DRILL BIT WITH QUICK COUPLING, 2-FLUTED, ø 2.5 MM, 154/180 MM
• Common Device Name: LOWER TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER BOIMET GMBH SWITZERLAND; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 15400098
• Report Number: 0009613350-2022-00428
• Device Sequence Number: 5056784
• Product Code: HTW
• UDI-Device Identifier: 00889024298064
• UDI-Public: (01)00889024298064(11)141209(10)14092857
• 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): 01/25/2023

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: 14092857
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2014
• 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: Unknown
• 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: Hospitalization; Other
• Patient Sex: Prefer Not To Disclose