MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 7 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	40-20907S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2019
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
The hospital reported the following event: "the surgeon requested a 7-hole fibula plate box called 7t given.At the opening the plate is a 9 holes".
Additional Manufacturer Narrative
Correction: section d10, h3 the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.However, based on investigation, the root cause was attributed to be user related.Such a mix up issue of the two product cat # 40-20907s and cat # 40-20909s cannot occur as the two parts were manufactured in two different locations.Most probably, the failure was caused by a confusion while counting the number of plate's holes.In this case, counting the two last holes in the 7-hole plate shaft could led to such an incident.Therefore, this case is considered as a user related issue.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
The hospital reported the following event : "the surgeon requested a 7-hole fibula plate box called 7t given.At the opening the plate is a 9 holes".

• Brand Name: DISTAL LATERAL FIBULA PLATE, 7 HOLE, STERILE
• 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: 8651567
• Report Number: 0008031020-2019-00519
• Device Sequence Number: 11428740
• Product Code: KTT
• UDI-Device Identifier: 04546540604651
• UDI-Public: 04546540604651
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 12/19/2023
• Device Catalogue Number: 40-20907S
• Device Lot Number: 1000333045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1