MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	110010733
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it¿s location is not known; 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 a metal shard from the inserter was found in the patient on x-ray and subsequently was removed.There were no further medical interventions necessary.There is no further information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d1, d4, g3, g6, h2, h11.
Event or Problem Description
It was reported that a metal shard from the flexible drill was found in the patient and removed.The instrument was a reused device.There is no further information available.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 h11 visual examination of the provided pictures identified a metallic piece of the device has fractured.No further evaluation could be made from the provided pictures.Lot identification is necessary for review of device history records, lot identification was not provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a small retained foreign body is present.A definitive root cause cannot be determined.The complaint is confirmed based on the x-ray findings and provided pictures.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 information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2.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
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.The following sections were corrected: d2a.Visual examination of the returned product identified the silicone sleeve and junction ends showed signs of previous uses.Black silicone sleeve was able to be rolled back to expose the spring damage.Flexible shaft showed fractured springs at the distal junction end.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause is unchanged.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 information is available at the time of this report.

• Brand Name: FLEXIBLE SILICONE DRILL DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 21880962
• Report Number: 0001825034-2025-01167
• Device Sequence Number: 15613505
• Product Code: LXH
• UDI-Device Identifier: 00880304569126
• UDI-Public: (01)00880304569126(11)201123(10)197049
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/07/2025

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 Catalogue Number: 110010733
• Device Lot Number: 197049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/18/2025; 05/06/2025; 06/02/2025; 11/04/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/29/2025; 05/08/2025; 06/24/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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