MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	18060080S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the hospital opened an expired guide wire.The procedure was completed successfully, and no adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
The reported event was not caused by a deficiency of the device as the expiry date was clearly legible on the label.Review of the device history records of the device reported did not indicate any conspicuities; the dhr contain a copy of the label set (label for packaging and patient record label).All labels indicate end of shelf life by (end of) february 2019 (nominal value).Finally, the expiry date should have been noticed prior to opening as it is obviously identifiable.According to available labels in the dhr the expiry date was clearly legible.Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to an inadequate environmental control at user site, therefore classified as a user-customer-shelf-life exceeded issue.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be updated accordingly.
Event or Problem Description
It was reported that the hospital opened an expired guide wire.The procedure was completed successfully, and no adverse consequences or surgical delay were reported.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8483031
• Report Number: 0009610622-2019-00139
• Device Sequence Number: 2758641
• Product Code: LPH
• UDI-Device Identifier: 04546540195890
• UDI-Public: 04546540195890
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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 Expiration Date: 02/28/2019
• Device Catalogue Number: 18060080S
• Device Lot Number: K04675E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR