MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO, STERILE T2 FEMUR Ø4,2X180 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18064270S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
Event or Problem Description
It was reported that, during a primary procedure for a right femoral im nail, as the surgeon was drilling for the proximal interlock screw, the tip of the drill bit broke in the patient.The broken portion was left in the patient.The case was completed successfully with no adverse consequences or surgical delay reported.On 26-jul-2019: medwatch form ((b)(4)) was received for this same event and stated "during procedure the tip of the drill bit broke off and retrieval unsuccessful.".
Event or Problem Description
It was reported that, during a primary procedure for a right femoral im nail, as the surgeon was drilling for the proximal interlock screw, the tip of the drill bit broke in the patient.The broken portion was left in the patient.The case was completed successfully with no adverse consequences or surgical delay reported.26-jul-19: medwatch form (b)(4) was received for this same event and stated "during procedure the tip of the drill bit broke off and retrieval unsuccessful.".
Additional Manufacturer Narrative
The complaint report stated that the surgeon executed a ¿freehand proximal locking technique¿ for ¿static locking¿ using a drill, ao, sterile t2 femur ø4,2x180 mm drill bit.In line with operative technique guide recommendations for freehand proximal locking technique.The drill, ao, sterile t2 femur ø4,2x230 mm drill bit should be used for this procedure.The drill, ao, sterile t2 femur ø4,2x180 mm drill bit is recommended for the freehand distal locking technique.Based on information provided, the root cause was attributed to a user related issue.The failure was caused by the selection and use of an alternate drill bit of a smaller length to the recommended drill bit for the executed procedure.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO, STERILE T2 FEMUR Ø4,2X180 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
• MDR Report Key: 8843532
• Report Number: 0009610622-2019-00595
• Device Sequence Number: 10827947
• Product Code: HWE
• UDI-Device Identifier: 04546540196811
• UDI-Public: 04546540196811
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2019

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: 04/30/2024
• Device Catalogue Number: 18064270S
• Device Lot Number: K07659E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR