MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DISTAL LATERAL FIBULA PLATE, 5 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	40-20905S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that distal lateral fibula plate, 5 hole, sterile was alleged of 'no locking effect' could not be confirmed, since the device was not returned for evaluation and no other evidences were 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 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was discarded.
Event or Problem Description
During variax fibula surgery, a locking screw did not lock to a distal hole of a variax fibula plate.The surgeon exchanged it to a new screw but the situation did not change.There was approx.3 min delay in the surgery.The surgeon did not insert any screw to the screw hole.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 5 HOLE, STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 6308750
• Report Number: 0008010177-2017-00025
• Device Sequence Number: 443332
• Product Code: KTT
• UDI-Device Identifier: 04546540604637
• UDI-Public: (01)04546540604637(17)201219(10)1000194799
• Combination Product (Y/N): N
• PMA/510(K) Number: K081284
• 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): 02/07/2017

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: 12/19/2020
• Device Catalogue Number: 40-20905S
• Device Lot Number: 1000194799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 02/07/2017
• 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
• Patient Age: 18 YR