MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL IMPLANT

Catalog Number UNK_KIE

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Impaired Healing (2378)

Event Date 05/01/2009

Event Type  Injury  

Manufacturer Narrative

Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device disposition unknown.

Event Description

The manufacturer became aware of a study from department of orthopaedics, ipswich general hospital, ipswich, australia which was published in september 2015. The title of this study is ¿retrograde intramedullary tibiotalocalcaneal (hindfoot) arthrodesis with concomitant midfoot and forefoot corrections¿ and is associated with the stryker t2 ankle arthrodesis nailing system. Within that publication, post-operative complications/ adverse events were reported, which occurred between may 2009 and may 2013. It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the event has not been reported by the hospital or by the author of the publication, therefore 10 complaint was initiated retrospectively for the different adverse event mentioned in the report. This product inquiry addresses nonunion. 1 out of 3 cases. The study states that, "of our patients that have nonunion (3 patients, 5%), all are diabetic with charcot arthropathy affecting the hindfoot and aged 53, 63, and 73 years. The tibiotalar joint failed to fuse in all 3 instances. However, successful limb salvage has been achieved through ongoing customized, immobilizing footwear. Outcomes: psuedoarthrosis, pain free, weight-bearing. ¿.

• Brand Name: UNKNOWN T2 ANKLE ARTHRODESIS NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8544203
• MDR Text Key: 143244413
• Report Number: 0009610622-2019-00221
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/15/2019
• 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 Treatment Data

Date Received: 04/24/2019 Patient Sequence Number: 1