MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-4260
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Part of device is implanted; other part unknown.
Event or Problem Description
Drills broke during medical procedure and remain in the patients bone.
Additional Manufacturer Narrative
Correction: refer to d4-lot code.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.Both the broken segments were returned for evaluation so as per the event, "drill bit remaining inside the patient" is not confirmed.The device inspection revealed the following: the received drill shows signs of intense usage.The drill was found to be broken from the shaft region.The flutes are absolutely blunt and severe material deformation can also be seen around it.The breakage surface reveals a relatively smoother surface at the center than towards the edges.This confirms a brittle fracture followed by abrupt breakage towards the edges (irregular surface observed).The edges of the breakage surface also shows permanent deformation, thus plastic deformation is also there.All these signs are evident enough to suggest that there was an intense and abnormal usage of the drill to an extent of heat build-up and ultimate forced fracture.As per the dimensional inspection and hardness testing, the returned drill was found to be within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.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 evident by the breakage surface and plastic deformation on the edges.The flutes of the drill were also significantly blunt.Under such a situation, the drill encounters a lot of stress which leads to a sudden breakage (brittle), as in this case.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Drills broke during medical procedure and remain in the patients bone.

• Brand Name: DRILL, AO T2 FEMUR Ø4,2X340 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: 9584525
• Report Number: 0009610622-2020-00013
• Device Sequence Number: 535209
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: 04546540196767
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: KU116083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1