MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 Ø3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18063540
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During shoulder nail implantation surgery while drilling reusable drill broke and part of it remain in the bone as it was not possible to remove it.Part of the drill remained in patient.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
During shoulder nail implantation surgery while drilling reusable drill broke and part of it remain in the bone as it was not possible to remove it.Part of the drill remained in patient.
Additional Manufacturer Narrative
Correction - please refer to g1 reporting contact.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The received drill is broken from the tip and the broken fragment was not returned.Broken surface of the drill appears relatively smooth without showing any plastic deformation signs which indicates towards a brittle failure of the drill due to bending and torsional overload leading to instantaneous breakage of the drill.Relevant dimensions were measured and found within specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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.Based on the provided image of the x-ray image, medical opinion was sought from medical expert which indicated that ¿the drill bit seems out of line with the angled hole in the nail.However, this can also be due to changing the position of the nail slightly after the breaking of the drill.A new hole needed to be drilled, so the nail had to be moved more proximal.¿ based on the investigation, the root cause was attributed to be user related.The event was caused by the application of excess torsional and bending forces during usage.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO T2 Ø3,5X230 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21246728
• Report Number: 0008031020-2025-00222
• Device Sequence Number: 15566084
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: (01)04546540196606(11)220324(10)K019197
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: 18063540
• Device Lot Number: KU146591
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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: Required Intervention
• Patient Sex: Unknown