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	1806-3545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that during the proximal drill, the surgeon forgot that the guide rod was inserted in the nail, and the tip of the drill was damaged.The damaged part was left attached to the nail.
Event or Problem Description
It was reported that during the proximal drill, the surgeon forgot that the guide rod was inserted in the nail, and the tip of the drill was damaged.The damaged part was left attached to the nail.
Additional Manufacturer Narrative
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 severe damage with an abrupt & inconsistent breakage.The cutting edges of the drill show severe deformation caused most likely due to some metallic contact.The breakage surface reveals typical characteristics of a brittle fracture i.E.Relatively smoother surface at the centre than at the edges.A hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.No indications of material or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to be user related.The appearance of breakage surface and cutting edges indicate towards an intense usage with an interaction with a metallic part leading to a forced brittle fracture.The event description also suggests that the guide rod was not removed before drilling, which most likely interacted with the drill.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: 12069626
• Report Number: 0009610622-2021-00581
• Device Sequence Number: 17133524
• Product Code: HWE
• UDI-Device Identifier: 04546540196620
• UDI-Public: 04546540196620
• 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): 09/09/2021

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: 1806-3545
• Device Catalogue Number: 18063545
• Device Lot Number: KKM874344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1