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	Foreign Body In Patient (2687)
Date of Event	08/01/2020
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
The customer reported to our technical service that : "in early august, one of our operating room teams had a problem with a drill bit for nailing, ref.1806-4260, sn (b)(4).When the drill bit was used to make the hole for the femoral nail, it broke during insertion and a piece remained in the patient's bone.In direct action, our biomedical workshop proceeded to acquire a new drill bit.The broken drill bit is in my possession if it is necessary to recover it for expertise.".
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
The customer reported to our technical service that : "in early august, one of our operating room teams had a problem with a drill bit for nailing, ref.1806-4260, sn (b)(6).When the drill bit was used to make the hole for the femoral nail, it broke during insertion and a piece remained in the patient's bone.In direct action, our biomedical workshop proceeded to acquire a new drill bit.The broken drill bit is in my possession if it is necessary to recover it for expertise.".
Event or Problem Description
The customer reported to our technical service that : "in early august, one of our operating room teams had a problem with a drill bit for nailing, ref.1806-4260, sn (b)(6).When the drill bit was used to make the hole for the femoral nail, it broke during insertion and a piece remained in the patient's bone.In direct action, our biomedical workshop proceeded to acquire a new drill bit.The broken drill bit is in my possession if it is necessary to recover it for expertise.".
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 shows significant signs of usage.The other broken segment was not returned for evaluation.The fracture surface exhibits typical signs of a brittle fracture, evident by a relatively smooth surface, caused most likely due to excessive bending load.The shaft diameter of the drill was observed to be 4.17mm against the required diameter in the range of 4.10mm to 4.20mm.Similarly, the average hardness of the drill was observed to be 53.1 hrc against the required hardness in the range of 53.0hrc to 57.0hrc.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 indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to be user related.The appearance of breakage surface indicates towards a forced brittle fracture caused most likely due to excessive bending load.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; GM D-24232
• MDR Report Key: 11127659
• Report Number: 0009610622-2021-00111
• Device Sequence Number: 3878107
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2021

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 Model Number: 1806-4260
• Device Catalogue Number: 18064260
• Device Lot Number: KU99300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/27/2021; 07/15/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/24/2021; 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1