MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066170
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2019
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 was disposed.
Event or Problem Description
Patient came in with a midshaft femur fracture.The patient already had an old competitor hip screw from an unknown date.Using the stryker extraction sets, surgeon tried a few options to take the competitor device out but could not get it out.A last resort option he tried the conical extractor (b)(4), the extractor became tight and then boke 3/4 the way up the threads.From that point the end of the extractor was stuck in the competitor device which is still in the patient.Surgeon decided to then plate the femur instead of removing the hardware and nailing it.

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 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: 8304868
• Report Number: 0009610622-2019-00063
• Device Sequence Number: 19362945
• Product Code: LXH
• UDI-Device Identifier: 04546540510068
• UDI-Public: 04546540510068
• 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
• Report Date (Section B): 02/05/2019

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: Health Professional
• Device Catalogue Number: 18066170
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other