MAUDE Adverse Event Report: ZIMMER BIOMET, INC. A/R SCREW DRILL; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the drill tip broke inside the patient.There was no foreign body retained.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: end level lot #¿s: 126400, 982050, 982040, 982020, 917010, 872550, 775720, 775670, 775660, 775080, 775090.Expiration dates: lot 126400- mar 4, 2031, lot 982050- mar 3, 2031, lot 982040- mar 10, 2031, lot 982020- feb 23, 2031, lot 917010- mar 2, 2031, lot 872550- jan 28, 2031, lot 775720- jan 27, 2031, lot 775670- jan 27, 2031, lot 775660- jan 28, 2031, lot 775080- feb 2, 2031, lot 775090- feb 11, 2031.H4: manufacturing dates: lot 126400- mar 4, 2021, lot 982050- mar 3, 2021, lot 982040- mar 10, 2021, lot 982020- feb 23, 2021, lot 917010- mar 2, 2021, lot 872550- jan 28, 2021, lot 775720- jan 27, 2021, lot 775670- jan 27, 2021, lot 775660- jan 28, 2021, lot 775080- feb 2, 2021, lot 775090- feb 11, 2021.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11 visual examination of the returned product identified one a/r screw drill was returned and the tip is fractured.Upon visual inspection there are wear lines on the shaft of the device, including near the fractured tip location, that appear to be consistent with repeated use of the device.Part and supplier lot number confirmed from etch.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event for lot 126400.Review of the device history record(s) identified no deviations or anomalies during manufacturing for the remaining lots.The returned drill, which is a single-use instrument, has markings throughout the product which appear to be consistent with repeated use.However, per follow up communications, it is unknown if this device has been used previously.Therefore, a definitive root cause cannot be determined.The reported fracture event is confirmed from product return.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 further event information is available at the time of this report.

• Brand Name: A/R SCREW DRILL
• Common Device Name: INSTRUMENT, HIP
• 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: 18606387
• Report Number: 0001825034-2024-00160
• Device Sequence Number: 16831143
• Product Code: HTW
• UDI-Device Identifier: 00887868023484
• UDI-Public: (01)00887868023484(17)310304(10)126400
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2024

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: N/A
• Device Catalogue Number: 211201505
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 05/31/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/22/2024; 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female