MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-4260
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "during a ankle arthrodesis t2 nail, drill bit broke off inside the patient and could not be removed.The surgery did not cause any harm to the patient, but it was not possible to insert the postero-anterior screw in the calcaneus.There was a delay of about 20 minutes trying to get the broken piece out".
Event or Problem Description
As reported: "during a ankle arthrodesis t2 nail, drill bit broke off inside the patient and could not be removed.The surgery did not cause any harm to the patient, but it was not possible to insert the postero-anterior screw in the calcaneus.There was a delay of about 20 minutes trying to get the broken piece out".
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was returned for evaluation.Please also note the correction to h6 method code.The reported event could be confirmed, since the device was returned, and matches the alleged failure.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 torsional and bending load.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with 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 be user related.The appearance of breakage surface indicates towards a forced brittle fracture caused most likely due to torsional and bending load.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO T2 FEMUR Ø4,2X340 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16141784
• Report Number: 0009610622-2023-00009
• Device Sequence Number: 17774485
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: 04546540196767
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: KU141138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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 Age: 57 YR
• Patient Sex: Male