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

Model Number 40-20904S

Device Problem Positioning Failure (1158)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "changed from 4 holes plate to 5 holes plate due to poor locking of locking of the screw.Attempt to use the same screw, and 5 holes were locked.".

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the plate was returned and analyzed.Some of the screw holes show a slight deformation of metal where the hcp tried to incorporate the screws during the operation.Those screw holes were tested with randomly selected t10 variax 2 screws, which locked perfectly into the plate.The event could therefore not be confirmed.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.

Event Description

As reported: "changed from 4 holes plate to 5 holes plate due to poor locking of locking of the screw.Attempt to use the same screw, and 5 holes were locked.".

• 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 ; SZ 2545
• MDR Report Key: 10398771
• MDR Text Key: 203497260
• Report Number: 0008031020-2020-02160
• 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: 10/06/2020

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
• Device Operator: Health Professional
• Device Model Number: 40-20904S
• Device Catalogue Number: 40-20904S
• Device Lot Number: 1000386536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1