MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SHAFT COMPLETE FOR 1806-1095 T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061097
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Upon incoming inspection it was noticed that the device was broken and unusable.No further information available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned and is fully functional.More detailed information about the complaint event, such as with which other instrument this device was used during the operation is necessary in order to determine the reason it was reported to be non-functional.A 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.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
Upon incoming inspection it was noticed that the device was broken and unusable.No further information available.

• Brand Name: SHAFT COMPLETE FOR 1806-1095 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: 8434720
• Report Number: 0009610622-2019-00116
• Device Sequence Number: 2205714
• Product Code: LXH
• UDI-Device Identifier: 04546540559364
• UDI-Public: 04546540559364
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 05/03/2019

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: No Information
• Device Catalogue Number: 18061097
• Device Lot Number: K0C3DBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1