MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FREEHAND DRILL IMN INSTRUMENTS Ø4.2X185MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2351-4218S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2022
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.The tip of the drill was left in the patient and the rest was placed in the sharps container.
Event or Problem Description
It was reported that the surgeon was implanting an antegrade femoral nail.Once the nail was placed, two proximal screws were placed in the nail.As the surgeon drilled for the distal locking screw the drill bit went in at a slight angle, at that time the drill bit torqued against the nail and the tip of the drill broke off.Not wanting to cause anymore trauma to the patient, the surgeon left the tip of the drill bit and proceeded to lock the other distal holes.
Event or Problem Description
It was reported that the surgeon was implanting an antegrade femoral nail.Once the nail was placed, two proximal screws were placed in the nail.As the surgeon drilled for the distal locking screw the drill bit went in at a slight angle, at that time the drill bit torqued against the nail and the tip of the drill broke off.Not wanting to cause anymore trauma to the patient, the surgeon left the tip of the drill bit and proceeded to lock the other distal holes.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no additional information was available.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 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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any further information is provided or the device is returned, the complaint report will be updated.

• Brand Name: FREEHAND DRILL IMN INSTRUMENTS Ø4.2X185MM
• 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: 16223526
• Report Number: 0009610622-2023-00014
• Device Sequence Number: 12183019
• Product Code: LXH
• UDI-Device Identifier: 07613327350319
• UDI-Public: 07613327350319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/23/2023

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 Expiration Date: 03/31/2024
• Device Model Number: 2351-4218S
• Device Catalogue Number: 23514218S
• Device Lot Number: K02A93E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male