MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS3 DISTAL MEDIAL TIBIAL PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was having surgery for a non-union of the distal tibia.Axsos3 distal medial tibial plate with screws was revised (2 screws were broken) and replaced with another axsos3 distal medial tibial plate.Surgeon believes there were signs of metallosis.

Manufacturer Narrative

Please note corrections to concomitant medical products and device evaluated by mfr.The reported event that unknown axsos3 distal medial tibial plate was alleged of 'implant breakage after surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided despite multiple attempts.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.Note that the following was reported: patient was having surgery for a non-union of the distal tibia.Surgeon believes there were signs of metalosis.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

Patient was having surgery for a non-union of the distal tibia.Axsos3 distal medial tibial plate with screws was revised (2 screws were broken) and replaced with another axsos3 distal medial tibial plate.Surgeon believes there were signs of metalosis.

• Brand Name: UNKNOWN AXSOS3 DISTAL MEDIAL TIBIAL PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8182796
• MDR Text Key: 130975555
• Report Number: 0008031020-2018-01088
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention