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	08/01/2018
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
When the surgeon tried to re-drill a proximal oblique hole of t2gtn which was once drilled, the drill broke off inside the patient's bone with noise like the drill and the nail interfering.The broken drill was completely removed from the patient.The surgery was continued with another same one.
Event or Problem Description
When the surgeon tried to re-drill a proximal oblique hole of t2gtn which was once drilled, the drill broke off inside the patient's bone with noise like the drill and the nail interfering.The broken drill was completely removed from the patient.The surgery was continued with another same one.
Additional Manufacturer Narrative
The reported event that drill, tri-flat t2 femur ø4,2x340 mm was alleged of issue -a (instruments - drill - broken) could be confirmed, since the device was returned for evaluation and it matches the alleged failure mode.Visual inspection of the returned device confirmed that the drill was broken.The breakage surface shows smooth structure.Plastic deformation was not found.Based on the visual inspection of fractured surface it can be concluded that the product has undergone typical brittle fracture due to high torsional overload.The device history record was not reviewed as stryker devices are inspected before being released for distribution, if any deviation would have been noticed, a nonconformance would have been raised.This is the first reported case with this lot number, the device can be therefore confirmed faultless prior the distribution.A review of the labeling did not indicate any abnormalities.Based on the investigation, the most likely root cause is attributable to a user (us) related issue (improper handling or use of device).The breakage may be caused by drilling under misalignment and / or contact with a nail.Moreover, it has to be ascertained that the cutting edges of the drill returned are covered with dents.The use of a drill with dents on cutting edges requires unintended high forces to achieve a drilling progress at all.Further, it cannot be excluded that the drill returned had been pre-damaged during former surgeries.The brochure ¿instructions for cleaning, sterilization, inspection and maintenance¿ help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.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: 7827320
• Report Number: 0009610622-2018-01038
• Device Sequence Number: 1720017
• 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): 01/03/2019

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: KU91267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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