MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 HUMERUS 3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-3545S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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
It was reported: "during the operation for humerus, and after inserting the nail, the drilled to insert the proximal lateral screw, but the tip of the drill broke.It was considered that the cause was that the patient was young and had good bone quality.Since there are two drills in the instrument, the used another drill and the ope completed without problem." additional information received: it seemed that the drill was in contact with the guide wire not the nail.There was an error in the procedure: the guide wire should be pulled out first then should drill.But the guide wire was not pulled out and drilled.The surgeon confirmed that it was procedure error.The tip of the drill was removed, as well as other metal debris.
Event or Problem Description
It was reported: "during the operation for humerus, and after inserting the nail, the drilled to insert the proximal lateral screw, but the tip of the drill broke.It was considered that the cause was that the patient was young and had good bone quality.Since there are two drills in the instrument, the used another drill and the ope completed without problem." additional information received: it seemed that the drill was in contact with the guide wire not the nail.There was an error in the procedure: the guide wire should be pulled out first then should drill.But the guide wire was not pulled out and drilled.The surgeon confirmed that it was procedure error.The tip of the drill was removed, as well as other metal debris.
Additional Manufacturer Narrative
Correction: please refer to catalog & gtin number.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received drill shows signs of intense usage and slightly worn out cutting edges.The fracture surface exhibits typical signs of a sudden brittle fracture, evident by a relatively smooth surface.The shaft diameter of the drill was observed to be 3.47mm against the required diameter in the range of 3.40mm to 3.50mm.Similarly, the average hardness of the drill was observed to be 53.0 hrc against the required hardness in the range of 53.0hrc to 57.0hrc.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Through the additional information received, it was observed that during the surgery the operating surgeon drilled inside the bone with a guide wire in place.An interaction with any metal object can considerably reduce the strength of the device, which is the most likely reason of the sudden breakage of the nail.Hence the root is attributed to a user related issue.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, TRI-FLAT T2 HUMERUS 3,5X230 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
• MDR Report Key: 11645687
• Report Number: 0009610622-2021-00439
• Device Sequence Number: 19596077
• Product Code: HWE
• UDI-Device Identifier: 04546540196637
• UDI-Public: 04546540196637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 1806-3545S
• Device Catalogue Number: 18063545
• Device Lot Number: KU95030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1