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

Model Number	1806-3540
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during the drilling to the proximal holes of t2ph nail, the drill broke off.There is no debris in the patient.".
Event or Problem Description
As reported: "during the drilling to the proximal holes of t2ph nail, the drill broke off.There is no debris in the patient.".
Additional Manufacturer Narrative
The reported event could be confirmed.The identification of the returned device was confirmed based on the catalog # and the lot # marked.The drill is broken off, at approximately 30 mm from the tip, the broken fragment was also returned.The functionality of the device cannot be given anymore.The reported failure was confirmed.The tip of the drill and the cutting edges are blunt and worn out, showing signs of intensive usage.The broken surface points towards a sudden brittle fracture, which can be confirmed by the absence of deformation and the shiny areas visible around the breakage.The fracture resulted most probably from excessive bending and/or torsional load.¨ a dimensional and a hardness test according to rockwell were performed and indicate the device and the material being in accordance to the values in the specifications.Based on investigation, the root cause was attributed to a combination of user and material wear related issues.The failure was most probably caused by excessive bending and/or torsional load applied to an already worn out device after 7 years of usage.As a reminder, the instructions for use clearly state: "¿ ensure that the drilling and cutting tools to be used are sharp; discard them if they are not." 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: DRILL, AO T2 HUMERUS Ø3,5X230 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15631800
• Report Number: 0009610622-2022-00469
• Device Sequence Number: 5797735
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: 04546540196606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 1806-3540
• Device Catalogue Number: 18063540
• Device Lot Number: KU57246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2015
• 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: Male