MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 6 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	40-20906S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon went to insert screw to the hole the locking did not work properly.Same screw worked properly at another hole.They did not insert any screw in the screw hole.They used other screw holes and completed surgery.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that when the surgeon went to insert screw to the hole the locking did not work properly.Same screw worked properly at another hole.They did not insert any screw in the screw hole.They used other screw holes and completed surgery.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 6 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
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16805931
• Report Number: 0008031020-2023-00164
• Device Sequence Number: 1804675
• Product Code: KTT
• UDI-Device Identifier: 04546540604644
• UDI-Public: 04546540604644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 09/23/2026
• Device Model Number: 40-20906S
• Device Catalogue Number: 40-20906S
• Device Lot Number: 1000463530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Male