MAUDE Adverse Event Report: STRYKER GMBH T2 - DRILL, TRI-FLAT D3.5X130 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18063555
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the drill bit broke and was left inside the patient's humerus, and the surgery was completed.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the drill bit broke and was left inside the patient's humerus, and the surgery was completed.".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned part was confirmed based on the catalog # and the lot # marked.Visual inspection of the tri-flat t2 tibia drill confirmed that the tip of the device had broken off.The broken tip could not be returned.The microscopic images show shiny fracture sites, which indicate a brittle fracture.This may have been caused by stressing the material beyond its limits.The root cause of the breakage could have been severe mechanical overloading of the drill by the user.In the case of manufacturing-related deviations, these would have been noticed at the beginning.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: T2 - DRILL, TRI-FLAT D3.5X130 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22310695
• Report Number: 0008031020-2025-00996
• Device Sequence Number: 15453033
• Product Code: HWE
• UDI-Device Identifier: 04546540196644
• UDI-Public: (01)04546540196644(10)K0B2451
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 18063555
• Device Lot Number: KU156389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 60 KG