MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2MMX20MM RNGLC+ ACET DRL BIT; INSTRUMENT, HIP

Catalog Number	31-323220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan 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 will be submitted.
Event or Problem Description
It was reported that during the procedure, the drill bit fractured.All the pieces were recovered during the procedure.There was no harm or health consequences to the patient.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - drill.Visual examination of the provided pictures identified the drill bit to be broken as reported.The event is confirmed based on an evaluation of the provided photos.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive 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 to report at this time.

• Brand Name: 3.2MMX20MM RNGLC+ ACET DRL BIT
• 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: 17449967
• Report Number: 0001825034-2023-01803
• Device Sequence Number: 20674232
• Product Code: LXH
• UDI-Device Identifier: 00887868478697
• UDI-Public: (01)00887868478697(17)330404(10)65975056
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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 Catalogue Number: 31-323220
• Device Lot Number: 65975056
• Was Device Available for Evaluation?: No
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown