MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060085S
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Retained by hospital.
Event or Problem Description
It was reported that the patient's right hip was revised due to infection.This sterile-packaged guide wire was used during the primary surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.Already at filing it was stated ¿that no further information is available due to hospital policy.¿ 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.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.
Event or Problem Description
It was reported that the patient's right hip was revised due to infection.This sterile-packaged guide wire was used during the primary surgery.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 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: 8571243
• Report Number: 0009610622-2019-00233
• Device Sequence Number: 16204017
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: 04546540195937
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 18060085S
• Device Lot Number: K030320
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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: Required Intervention
• Patient Age: 52 YR