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

Model Number	40-20904
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the 4 distal holes ("clover shaped") of the small fibular plate did not have locking mechanisms, allowing screws to pass clean through the plate.A second plate was immediately available in the o.R.And was used with no surgical delay.
Additional Manufacturer Narrative
The reported event that distal lateral fibula plate, 4 hole was alleged of 'no locking effect & not functional' could be confirmed.Based on investigation, the root cause was attributed to be manufacturing related.The failure was caused by human error.Due to this deviation, an nc was opened to investigate further.The device inspection revealed the following: the visual inspection of the plate shows that indeed, the locking mechanism is lacking in 5 of the distal holes.The 4 proximal holes have been welded correctly.The absence of the locking mechanism does indeed allow the screws to go through the holes with no contact.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
It was reported that the 4 distal holes ("clover shaped") of the small fibular plate did not have locking mechanisms, allowing screws to pass clean through the plate.A second plate was immediately available in the o.R.And was used with no surgical delay.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 4 HOLE
• 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: 7397444
• Report Number: 0008031020-2018-00268
• Device Sequence Number: 1976720
• Product Code: KTT
• UDI-Device Identifier: 04546540567437
• UDI-Public: (01)04546540567437
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 06/07/2018

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 Model Number: 40-20904
• Device Catalogue Number: 40-20904
• Device Lot Number: 1000265470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/07/2018
• 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
• Patient Age: 59 YR