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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported, the drill interfered with the nail before screw insertion, resulting in breakage of the drill tip.
Additional Manufacturer Narrative
Correction - please refer to h6 health impact code.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, although there are minor chevron lines around the center from where the crack propagation initially happened which indicates towards a brittle failure of the drill due to mechanical overload leading to sudden breakage.Due to excess metallic contact, deformation seen on the cutting flutes of the drill and an excess torsional force along with bending forces resulted in the breakage of drill due to this excess metallic contact and misalignment of the drill during usage.The outer diameter of the drill was found within specification.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 investigation, the root cause was attributed to be user related.The event was caused by the application of excess torsional force along with bending forces due to misalignment of drill while usage.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, the drill interfered with the nail before screw insertion, resulting in breakage of the drill tip.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20947588
• Report Number: 0009610622-2024-00957
• Device Sequence Number: 12873790
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: (01)04546540196606(10)K02E5F8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 18063540
• Device Lot Number: KU156495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2022
• 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: 21 YR
• Patient Sex: Male