MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 40-20903S

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The procedure was fibula.The 16mm locking screw didn't lock on screw hole.Implanted another 16mm screw and complete the procedure with no issue.

Manufacturer Narrative

The reported event that distal lateral fibula plate, 3 hole, sterile was alleged of 'no locking effect' could not be confirmed.Based on investigation, the root cause was attributed to be user related event.The failure could have been caused most likely by an improper insertion of the screw into the plate.It was only received a screw.The plate was not received.The screw was inspected at the microscope and showed a small crack in the locking thread.Also, shows marks of rotational scratches in the locking area.This was probably the result of a grazing with the plate while insertion.Despite the screw damage, it was attempted to lock this screw into a straight fibula test plate and it locked appropriately.Most likely the non-locking event could have been resultant of a non precise insertion of the screw and a non adequate tightening.As the labeling states "one-step locking achieved by simply inserting a locking screw within the polyaxial locking range of ±15°".If this range is not respected the screw might not perform the locking appropriately.Thus the use of the drill guide is recommended as the "polyaxial drill guide allows placement of locking screws at a variable angle (up to ± 15°)".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.Device was not returned.

Event Description

The procedure was fibula.The 16mm locking screw didn't lock on screw hole.Implanted another 16mm screw and complete the procedure with no issue.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6062169
• MDR Text Key: 58821157
• Report Number: 0008010177-2016-00257
• Device Sequence Number: 1
• Product Code: KTT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

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 Catalogue Number: 40-20903S
• Device Lot Number: 1000217009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other