MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG (MDR) DISTAL LATERAL FIBULA PLATE, 6 HOLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 40-20906

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

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

Event Date 12/04/2014

Event Type  malfunction  

Event Description

It was reported that 2 screws would not lock into the four distal holes of an atomic variax fibula plate.There was an approximate 15 min delay trying to use another screw with that hole.They left the holes empty.

Manufacturer Narrative

The device will not be returned.Additional information was requested and if received will be provided on a supplemental report.Device will not be returned.

Manufacturer Narrative

Product inquiry stated the distal lateral fibula plate and both unknown locking screws to be the primary products.No further associated products were reported.A physical examination could not be carried out as the items were not received for evaluation.The distal lateral fibula plate was still implanted and the two locking screws were disposed of by the customer.A review of the device history records could not be carried out as the lot codes were unknown and could not be provided.Thus a reasonable examination and investigation was not possible.The reported event (¿2 screws would not lock into two of the four distal holes¿) could not be confirmed.With the information given the exact root cause could not be determined.However based on the limited information a deficiency of the items in question was not verified.The file will be closed formally.In case relevant information resp.The part becomes available we reserve the right to update the investigation and to change the root cause.

Event Description

It was reported that 2 screws would not lock into the four distal holes of an atomic variax fibula plate.There was an approximate15 min delay trying to use another screw with that hole.They left the holes empty.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 6 HOLE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg 79111 ; GM 79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg 79111 ; GM 79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4377116
• MDR Text Key: 5115456
• Report Number: 0008010177-2015-00003
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 40-20906
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 45 YR
• Patient Weight: 91