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

Catalog Number	18060050
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: remains inside the patient.
Event or Problem Description
During hip osteosynthesis surgery, the 3 x 285mm kirschener nail remained inside the femoral canal and it was not possible to remove it, which is why it remains inside the patient.Additional information: part number 18060050 is inside the patient and it is not broken.The k-wire remains inside the patient's bone.The gamma3 ti nail was implanted according to the technique that appears in the catalog and the surgeon always performs but this was the first time this problem happened.The event occurred during primary surgery which led to 40 minutes delay without any patient impact.Doctor decide to finish the surgery with 18060050 inside.Doctor tried to remove it at the time of the surgery without success.By the end he decided to keep it inside the bone and he mentioned he believes it would affect the patient.

• Brand Name: K-WIRE 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
• MDR Report Key: 8716033
• Report Number: 0009610622-2019-00494
• Device Sequence Number: 2004450
• Product Code: LXH
• UDI-Device Identifier: 04546540195845
• UDI-Public: 04546540195845
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: Lay User/Patient
• Device Catalogue Number: 18060050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1