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

Model Number	1806-4260
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2020
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.Device not available; unable to locate the specific drill or drill bit at this time.
Event or Problem Description
It was reported via medwatch #0505670000-2020-8007: "the drill broke off in the patient's femur." update 30/dec/2020 : from op report: ¿the lateral image appeared to show that the most distal screw was not within the nail.This was removed.The end cap was also removed and the jog was replaced.The most distal screw was re-drilled.However, this met with metallic resistance and when the drill was withdrawn, it appeared that the tip of the drill had broken off.Fluoroscopic images showed the drill tip embedded within the bone.A new drill was used, which also met with metallic resistance.It appeared that the screw was hitting one of the posts from the femoral component.The decision was made not to place the most distal screw.A more proximal transverse screw was placed through the jig.Final fluoroscopic images showed good femoral alignment and the drill tip was contained entirely within the bone.¿ complications: ¿broken drill bit within the distal femur¿.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.More information as well as the affected device must be returned to determine the exact root cause of the event.However, based on the past complaints, it is observed that most common cause of failure is user related, when a surgeon tries to apply too much of force (torsional and bending) on the drill to appreciate through the bone.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported via medwatch #: (b)(4): "the drill broke off in the patient's femur." update 30/dec/2020 : from op report: ¿the lateral image appeared to show that the most distal screw was not within the nail.This was removed.The end cap was also removed and the jog was replaced.The most distal screw was re-drilled.However, this met with metallic resistance and when the drill was withdrawn, it appeared that the tip of the drill had broken off.Fluoroscopic images showed the drill tip embedded within the bone.A new drill was used, which also met with metallic resistance.It appeared that the screw was hitting one of the posts from the femoral component.The decision was made not to place the most distal screw.A more proximal transverse screw was placed through the jig.Final fluoroscopic images showed good femoral alignment and the drill tip was contained entirely within the bone.¿ complications: ¿broken drill bit within the distal femur.¿.

• Brand Name: DRILL, AO, STERILE 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; GM D-24232
• MDR Report Key: 11168032
• Report Number: 0009610622-2021-00232
• Device Sequence Number: 3532709
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: 04546540196767
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Expiration Date: 02/28/2025
• Device Model Number: 1806-4260
• Device Catalogue Number: 18064260S
• Device Lot Number: K03985B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1