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

Catalog Number	18064265
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
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: "during t2 femoral surgery, the drills broke when they were used to drill for the static screw hole of the nail.The procedure was progressed without problem after that." no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the received drill shows significant evidence of frequent and intense use.The tip of drill is completely broken off.The fractography details revealed that the fracture origin was located, and the fracture was determined to be ductile.Elevated levels of chromium were detected within the isolated particles along the ductile fracture surface.Both fracture samples exhibit the same features, leading to this being a reproducible failure.Appearance of the fractured/broken surface as well as the ductile fracture suggested that the drill broke due to repetitive stress.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 labelling did not indicate any abnormalities.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Based on investigation, the root cause was attributed to a normal device wear.The failure was caused by bending forces in combination with high force application due to the bad cutting performance of the drill (blunt flutes).Also, the stress developed in the drill due to repetitive use over the years.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "during t2 femoral surgery, the drills broke when they were used to drill for the static screw hole of the nail.The procedure was progressed without problem after that." no adverse consequences or surgical delay reported.

• 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
• MDR Report Key: 9073059
• Report Number: 0009610622-2019-00694
• Device Sequence Number: 3660615
• 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): 12/26/2019

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: KU77873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 80