MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18064260
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when drilling for insertion of a pa screw into the calcaneus, the drill missed the screw hole and grazed the nail.When trying to remove the drill while turning, the drill bit broke off.When drilling again with a spare drill, it broke off in the same way".
Additional Manufacturer Narrative
Correction - please refer to h6 component code.The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned drill could be confirmed based on the catalog number and lot number marked.The device is broken at the beginning of its tip, confirming the reported event.The detached fragment was returned.The surface of the breakage gives indication of a sudden brittle fracture, resulting from excessive bending and/or torsion load.Dimensional and material integrity inspections showed the device to be within specification.Based on investigation, the root cause was attributed to an user related issue.The drill breakage occurred most probably due to excessive load applied.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.
Event or Problem Description
As reported: "when drilling for insertion of a pa screw into the calcaneus, the drill missed the screw hole and grazed the nail.When trying to remove the drill while turning, the drill bit broke off.When drilling again with a spare drill, it broke off in the same way".

• Brand Name: DRILL, AO T2 Ø4,2X340 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21883314
• Report Number: 0008031020-2025-00742
• Device Sequence Number: 8631477
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: 04546540196767
• 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): 06/17/2025

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: 18064260
• Device Lot Number: KU151538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male