MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HANDLE T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061002
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/30/2019
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.
Event or Problem Description
It was reported to the rep that upon inspection, the hole for the strike plate in the standard t2 tibia nail holding arm was observed to be counter-threaded and fraying.No associated procedure.

• Brand Name: NAIL HANDLE T2 TIBIA
• 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: 8824863
• Report Number: 0009610622-2019-00573
• Device Sequence Number: 2754888
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: 04546540196538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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: 18061002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1