MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL STANDARD 3.7 MM DIAMETER; BIT, DRILL

Catalog Number	00236022537
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the front part of the drill broke while drilling into the bone.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).D10: cat: 00236022537, lot: 62576541 drill standard 3.7 mm diameter.G2: foreign- (b)(6).Proposed g-code: mechanical (g04) - drill.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products identified both devices show wear and tear, and have fractured within the length of the cutting flutes.Device history record (dhr) was reviewed and no discrepancies were found.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03397.

• Brand Name: DRILL STANDARD 3.7 MM DIAMETER
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18241904
• Report Number: 0001822565-2023-03396
• Device Sequence Number: 20504654
• Product Code: HTW
• UDI-Device Identifier: 00889024061125
• UDI-Public: (01)00889024061125(11)170308(10)63610612
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 11/30/2023

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: 00236022537
• Device Lot Number: 63610612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• 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: Not provided
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 90 KG