MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MDLR FLX DRILL BIT 3.2 MM DIAMETER 30 MM LENGTH; INSTRUMENT, HIP

Catalog Number	00879000703
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan.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 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
This follow-up report is being filed to relay that the previous report submitted on aug 3, 2023 was submitted erroneously under the wrong manufacturing report number.This event is currently being submitted under 0001822565-2023-02623.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MDLR FLX DRILL BIT 3.2 MM DIAMETER 30 MM LENGTH
• 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: 17444526
• Report Number: 0001825034-2023-01800
• Device Sequence Number: 14115361
• Product Code: LXH
• UDI-Device Identifier: 00889024152212
• UDI-Public: (01)00889024152212(11)210427(10)65088232
• 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): 09/29/2023

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: 00879000703
• Device Lot Number: 65088232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• 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: 09/22/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2021
• 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