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	03/03/2020
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, reported by phone: "the drill broke during the procedure.There was a procedure delay.No further information available, we will provide you more details".Additionally reported by pharmacist: "i confirm materiovigilance notification on product 18064260, lot k227443.The event happened during procedure, when inserting the drill bit into the locking hole of the nail.There were no consequences on the procedure time (replacement of the drill with another available drill) or on the patient (easy removal of the 2 pieces).No medical intervention was necessary.".
Additional Manufacturer Narrative
Due to the current covid-19 pandemic it was not possible to inspect the product as the access to the facility is restricted.The investigation will be reassessed as soon as restriction is lifted.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Pharmacist, reported by phone: "the drill broke during the procedure.There was a procedure delay.No further information available, we will provide you more details".Additionally reported by pharmacist: "i confirm materiovigilance notification on product 18064260 lot k227443.The event happened during procedure, when inserting the drill bit into the locking hole of the nail.There were no consequences on the procedure time (replacement of the drill with another available drill) or on the patient (easy removal of the 2 pieces).No medical intervention was necessary.".
Event or Problem Description
Pharmacist, reported by phone: "the drill broke during the procedure.There was a procedure delay.No further information available, we will provide you more details".Additionally reported by pharmacist: "i confirm materiovigilance notification on product 18064260 lot k227443.The event happened during procedure, when inserting the drill bit into the locking hole of the nail.There were no consequences on the procedure time (replacement of the drill with another available drill) or on the patient (easy removal of the 2 pieces).No medical intervention was necessary.".
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 was found to be broken from the flute area.Flutes appear to be rather alright as opposed to generally observed deformation and damages after long and prolonged usage.The breakage surface reveals a relatively smoother surface at the centre than towards the edges, as also confirmed by the distal segment of the drill.This confirms a typical brittle fracture of the drill due to torsional and bending overload.As per the hardness testing, the returned drill was found to have an average hardness of 53.6 hrc against a required range of 52.0 to 56.0 hrc.Therefore, it was found to be well within specifications.A review of the device history for the reported lot did not indicate any abnormalities.Referring to the very long period since manufacturing [manufactured in 2010] it is safe to say the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.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 combined torsional and bending overload 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.

• 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: 9891479
• Report Number: 0009610622-2020-00131
• Device Sequence Number: 16275197
• 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,Followup
• Report Date (Section B): 08/26/2020

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: K227443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/28/2020; 07/30/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/21/2020; 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1