MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR 4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-4260
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2020
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
Pharmacist resident reported that : " while drilling the femur, the tip of the drill bit broke off and remained in the femur.Clinical consequences: increased operating time (time to remove the tip) with risk with a patient with a complicated femur fracture.The surgeon was able to remove the tip using a needle holder.The dm was retained and is available for expert evaluation." 10 minute delay.
Additional Manufacturer Narrative
The reported event that drill, ao t2 femur ø4,2x340 mm was alleged of issue ¿instrument - breakage during implantation¿ 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 was found to be broken from the mid flute area.Flutes appear to be rather alright as opposed to generally observed deformation and damages after long and prolonged usage, but it was still marginally worn out.Worn out edges reduces the overall cutting efficiency of the drill.The breakage surface reveals a relatively smoother topography with no plastic deformation.This confirms a typical brittle fracture of the drill due to bending overload.As per the hardness testing, the returned drill was found to be having an average hardness of 52.9 hrc against a required range of 52.0 to 56.0 hrc.Diameter of the shaft just above the breakage point was measured and was found as per required.Therefore, the drill was found to be well within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The breakage of the drill happened due to a bending overload (assisted by slightly worn out flutes) during the surgery resulting in a brittle fracture, evident by the breakage surface.Under such a situation, the drill encounters a lot of stress (along with the residual stress over a long period of use) which leads to a sudden breakage (brittle), as in this case.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Pharmacist resident reported that: " while drilling the femur, the tip of the drill bit broke off and remained in the femur.Clinical consequences: increased operating time (time to remove the tip) with risk with a patient with a complicated femur fracture.The surgeon was able to remove the tip using a needle holder.The dm was retained and is available for expert evaluation." 10 minute delay.

• Brand Name: DRILL, AO T2 FEMUR 4,2X340 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9922645
• Report Number: 0009610622-2020-00138
• Device Sequence Number: 3271858
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: 04546540196767
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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: 1806-4260
• Device Catalogue Number: 18064260
• Device Lot Number: KU52247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1