MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 FEMUR 4,2X340 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-4265
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
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
As reported: "the patient underwent the initial operation for femoral condyle.During the operation, the drill broke when drilling at the proximal target device.Successful rescue, no drill left in the body.".
Event or Problem Description
As reported: "the patient underwent the initial operation for femoral condyle.During the operation, the drill broke when drilling at the proximal target device.Successful rescue, no drill left in the body.".
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 signs of intense usage and severe damage with its major part of the flute broken apart and further having a broken tip.The edges of the broken segment show slight plastic deformation while the majority of the breakage surface indicates towards a brittle fracture.The cutting edges show severe damage and material erosion.The deformation observed on the broken tip suggests that there is a strong likelihood that the drill got stuck during use and in the event of excessive torsional and bending forces, the drill snapped.The critical diameter of the drill was observed to be 4.18mm against the required diameter in the range of 4.10mm to 4.20mm.Similarly, the average hardness of the drill was observed to be 53.5 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 corrective actions are required at this time.No indications of material, 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 and cutting edges indicate towards an intense usage leading to a forced brittle fracture.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, TRI-FLAT T2 FEMUR 4,2X340 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11168006
• Report Number: 0009610622-2021-00230
• Device Sequence Number: 11635139
• Product Code: HWE
• UDI-Device Identifier: 04546540196781
• UDI-Public: 04546540196781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 1806-4265
• Device Catalogue Number: 18064265
• Device Lot Number: KU111658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1