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

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2019

Event Type  malfunction  

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 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 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.

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
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8351649
• MDR Text Key: 136619484
• Report Number: 0008031020-2019-00067
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 04546540604620
• UDI-Public: 04546540604620
• Combination Product (y/n): N
• PMA/PMN Number: K081284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other