MAUDE Adverse Event Report: ZIMMER GMBH HUMERUS CALIBRATED DRILL, 3.3MM; TRAUMA, DRILL, INSTRUMENT

Catalog Number	110035650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): g2: report source italy.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
A broken drill bit was reported prior to surgery.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The reported product was returned to the product surveillance team for examination.A portion of the cutting edge of the drill has fractured off.The fragment was not returned.The remaining spiral fluting shows some signs of wear in the form of dents.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Reported event did not occur in an operating room or as part of a medical procedure; therefore, no medical records are available for review.Based on the available information, the reported event can be confirmed.However, a definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HUMERUS CALIBRATED DRILL, 3.3MM
• Common Device Name: TRAUMA, DRILL, INSTRUMENT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21355346
• Report Number: 0009613350-2025-00050
• Device Sequence Number: 20796892
• Product Code: HSB
• UDI-Device Identifier: 00889024506367
• UDI-Public: (01)00889024506367(10)4503741365
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200814
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 110035650
• Device Lot Number: 4503741365
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown