MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-4265
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2021
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 patient underwent surgery using t2scn for a supracondylar fracture after tka.When drilling was performed to insert the most distal screw, the drill contacted the nail or peg and broke off at about 4 cm from the tip.Additional information received on 10/29/2021: the procedure was completed successfully with a surgical delay of 30 mins.The tip of the broken drill remained in the patient's bone.
Additional Manufacturer Narrative
The reported event could be confirmed, since the drill bit is broken as complained.The device inspection revealed the following: the visual inspection has shown that a fragment of about 50mm length is broken off from the received drill bit, the fragment was not returned for evaluation.The remaining cutting edges are completely blunt, there are nicks and dents all over visible.The breakage surface reveals a smooth surface.This confirms a sudden brittle fracture.All the present signs are evident enough to suggest that there was an intense usage of the drill including high bending load which led to a forced brittle fracture.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mechanical overload due to an excessive metallic contact as described in the event description.If more information is provided, the case will be reassessed.
Event or Problem Description
The patient underwent surgery using t2scn for a supracondylar fracture after tka.When drilling was performed to insert the most distal screw, the drill contacted the nail or peg and broke off at about 4 cm from the tip.Additional information received on 10/29/2021: the procedure was completed successfully with a surgical delay of 30 mins.The tip of the broken drill remained in the patient's bone.

• Brand Name: DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: nathe hendricks ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12790816
• Report Number: 0009610622-2021-00783
• Device Sequence Number: 19831686
• 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): 03/02/2022

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: 10/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown