MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 110010717 g7 depth gauge 380316.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 depth gauge and drill draft broke while inserting the cup.No known impact or consequence to the patient.It was reported that no further information is available.
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 and corrected information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6;h10.The following section was corrected: d4.Product was returned and evaluated.Visual review of the flexible silicone driver showed that both junctions had wear from use.The black silicone sleeve had abrasion marks and was torn in the mid shaft area.No other damage was noted.Device had an approximate field age of 5.5 years.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.This complaint was confirmed via the returned product evaluation.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.

• Brand Name: FLEXIBLE SILICONE DRILL DRIVER
• Common Device Name: HIPS, INSTRUMENTS
• 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: 21700440
• Report Number: 0001825034-2025-00846
• Device Sequence Number: 8664282
• Product Code: HTW
• UDI-Device Identifier: 00880304569126
• UDI-Public: (01)00880304569126(11)191031(10)186344
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 110010733
• Device Lot Number: 186344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Female