MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS

Catalog Number	18064265
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
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
It was broken the drill during drilling was it was without noticing that the sleeve was displaced by the soft tissue during surgery and the drill did not through the nail.For that reason, the surgeon pulled our a broken drill tip form the opposite side where the drill tip was removed.The surgeon thinks that the sleeve was pushed by the softy tissue and believe it is not a malfunction.
Event or Problem Description
It was broken the drill during drilling was it was without noticing that the sleeve was displaced by the soft tissue during surgery and the drill did not through the nail.For that reason, the surgeon pulled our a broken drill tip form the opposite side where the drill tip was removed.The surgeon thinks that the sleeve was pushed by the softy tissue and believe it is not a malfunction.
Additional Manufacturer Narrative
The reported event that drill, tri-flat t2 femur ø4,2x340 mm was alleged broken could be confirmed, since the device was returned for evaluation and matches the reported failure mode.A physical examination of the received drill was performed and the drill showed traces of a frequent and intense use.The cutting thread of the drill is completely broken off.It was broken approx.55 mm from the tip.The broken off piece was also returned.The breakage surface shows a typical smooth surface of a forced brittle fracture.Plastic deformation along the breakage surface was not found.Based on investigation, the root cause was attributed to a user related issue.Appearance of the breakage surface as well as the absence of plastic deformation suggested that the drill broke in a sudden manner.It is not unlikely that drilling under misalignment and bending forces in combination with high force application due to the bad cutting performance had led to the final breakage of the drill.A review of the labeling did not indicate any abnormalities.According to the labelling review, sufficient guidelines are provided in the instruction for use that physicians should ensure that they are familiar with the intended uses, compatibility and correct handling of the instrument.It also mentions various precautions and care to be taken during the usage of the product to prevent any damage to the device.If any further information is provided, the complaint report will be updated.

• Brand Name: DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM
• Common Device Name: SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8257051
• Report Number: 0009610622-2019-00051
• Device Sequence Number: 19364681
• Product Code: HWE
• UDI-Device Identifier: 04546540196781
• UDI-Public: 04546540196781
• Combination Product (Y/N): N
• 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): 03/04/2019

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: 18064265
• Device Lot Number: KU91656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR