MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE, STERILE T2 FEMUR Ø3X285 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0050S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned for evaluation, but a device picture and intraoperative x-ray were shared by the customer through which we can confirm the event.In the provided picture, k-wire shows broken and indicated towards oblique insertion and forceful extraction.More detailed information as well as the affected device must be returned to determine the exact root cause.The provided device images and intra-op x-rays without multiple views are not enough to determine the exact root cause.One of the possible reasons of failure could be as provided in the picture, k-wire shows broken and indicated towards oblique insertion and forceful extraction.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was discarded.
Event or Problem Description
The customer reported that during a supracondylar nail case, the surgeon was drilling through the jig into one of the holes.The drill broke and the tip remained inside the patient.The surgeon was able to remove the broken piece.There was a 3 minute delay to surgery.The patient was young with hard bone.It is not known if the surgeon was drilling at an angle.Or putting pressure on the drill or if the drill touched the jig / other metal item.

• Brand Name: K-WIRE, STERILE T2 FEMUR Ø3X285 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9772383
• Report Number: 0009610622-2020-00087
• Device Sequence Number: 18993539
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: 04546540195852
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 02/28/2020

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: 06/30/2024
• Device Model Number: 1806-0050S
• Device Catalogue Number: 18060050S
• Device Lot Number: K085E6D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1