MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL STANDARD 2.7 MM DIAMETER; INSTRUMENT/TRAUMA

Catalog Number	00236020527
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.H6: component codes: mechanical (g04) - drill.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a surgery while the surgeon was using the instrument to drill the hole for the locking screw, the instrument struck the hip stem and fractured.The surgeon made the decision to leave the piece that fractured in the patient as they determined there would be no harm to the patient if the piece was retained.The surgeon does not plan to revise the patient to remove the foreign body.
Event or Problem Description
No further event information 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: b4; b5; d2; d4; d9; g2; g3; g6; h1; h2; h4 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: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.Visual examination of the returned product/provided pictures identified the returned drill bit shows signs of use with some wear and tear around the ao connecting feature at the proximal end of the drill bit.There is also some galling on the shaft of the drill bit near the distal end before the flutes of the drill.The flutes of the drill are also damaged, and the distal end of the drill bit has fractured and was not returned.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: reviewed a single intra-op fluoroscopy image.The image is post-drilling, and the allegation is for the drill hitting the implant and left in situ; therefore, submission would not enhance the investigation.The root cause of the reported issue is attributed to use error.Per the instructions for use "instrument/provisional use, care, and sterilization," "do not subject instruments to high loads and/or impact as breakage can occur." 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 event information available at the time of this report.

• Brand Name: DRILL STANDARD 2.7 MM DIAMETER
• Common Device Name: INSTRUMENT/TRAUMA
• 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: 21861781
• Report Number: 0001822565-2025-01028
• Device Sequence Number: 4721129
• Product Code: HTW
• UDI-Device Identifier: 00889024061118
• UDI-Public: (01)00889024061118(10)63599482
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00236020527
• Device Lot Number: 63599482
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/02/2025; 09/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/06/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2017
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown