MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 4 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	40-20904S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned, only the retrieved piece.If additional information becomes available it will be provided on a supplemental report.Device was implanted.
Event or Problem Description
It was reported that the scraped piece was confirmed after the all variax fibula implants were removed.Therefore, the piece was removed and the operation was finished.
Event or Problem Description
It was reported that the scraped piece was confirmed after the all variax fibula implants were removed.Therefore, the piece was removed and the operation was finished.
Additional Manufacturer Narrative
The reported event that distal lateral fibula plate, 4 hole, sterile was damaged could be confirmed.Based on investigation, the root cause was attributed to be user related.The device inspection revealed the following: note that only some metal swarf of the mentioned plate was returned, which was recovered after a planned revision ¿bone union¿.It is clearly evident, due to the shape and structure of this metal swarf, that the returned metal piece originated from the plate and not from the screw.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 any further information is provided, the investigation report will be updated.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 4 HOLE, STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8351649
• Report Number: 0008031020-2019-00067
• Device Sequence Number: 11256165
• Product Code: KTT
• UDI-Device Identifier: 04546540604620
• UDI-Public: 04546540604620
• Combination Product (Y/N): N
• PMA/510(K) Number: K081284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 02/28/2023
• Device Catalogue Number: 40-20904S
• Device Lot Number: 1000292889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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: Other