MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL 300 X 10MM; IMPLANT

Catalog Number UNK_KIE

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/01/2011

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 (b)(6).The title of this study is ¿tibiotalocalcaneal nail fixation and soft tissue coverage of gustilo¿anderson grade 3b open unstable ankle fractures in a frail population; a case series in a major trauma centre¿ and is associated with the t2 ankle arthrodesis nail.Within that publication, post-operative complications/ adverse events were reported, which occurred between 1 july 2011 and 30 june 2016.It was not possible to ascertain specific device catalogs from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 10 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery.

• Brand Name: UNKNOWN T2 ANKLE ARTHRODESIS NAIL 300 X 10MM
• 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: 8488728
• MDR Text Key: 141163264
• Report Number: 0009610622-2019-00151
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR