MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-4265
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when inserting a polar screw into the side of the nail, the hand of the surgeon became unstable and the drill was overloaded, resulting in breakage." update (b)(6) 2021 : no debris have been left in patient¿s body.The procedure could be completed successfully with a substitute.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: the received drill shows signs of intense usage which is evident from the cutting edges which are blunt and slightly damaged.The drill was found to be broken from around the middle of the flute region.The breakage surface reveals a smooth surface.This confirms a sudden brittle fracture which was caused due to the application of high bending and torsional load.As per the dimensional inspection and hardness testing, the returned drill was found to be within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to being user related.The appearance of breakage surface and cutting edges indicates an intense usage and application of high bending and torsional load, leading to a forced brittle fracture.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when inserting a polar screw into the side of the nail, the hand of the surgeon became unstable and the drill was overloaded, resulting in breakage." update 12/17/2021: no debris have been left in patient¿s body.The procedure could be completed successfully with a substitute.

• Brand Name: DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13156037
• Report Number: 0009610622-2022-00001
• Device Sequence Number: 5348702
• Product Code: HWE
• UDI-Device Identifier: 04546540196781
• UDI-Public: 04546540196781
• 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): 04/25/2022

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 Model Number: 1806-4265
• Device Catalogue Number: 18064265
• Device Lot Number: KU111657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2019
• 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 Sex: Unknown