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
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
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
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.".
Additional 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 or Problem 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
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10398771
• Report Number: 0008031020-2020-02160
• Device Sequence Number: 2705595
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2024
• 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 Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1