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

Catalog Number UNK_KIE

Device Problem Separation Problem (4043)

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

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from university of (b)(6) hospital, in usa.The title of this report is ¿a retrospective data collection of the treatment of the ankle with the t2 ankle arthrodesis nailing system¿ which is associated with the stryker ¿t2 ankle arthrodesis nailing¿ system.This report includes research done on 127 patients between the period april, 2019 and january, 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses partial backout and loosening of calcaneal screw.The report states: ¿(b)(6) year old female with a past medical history of diabetes mellitus (hga1c of 8.4) who underwent open reduction and internal fixation of a left ankle medial malleolus fracture on (b)(6) 2018.She subsequently developed a deep infection and was placed on iv antibiotics.She sustained an additional ground level fall with fracture displacement and underwent hardware removal on (b)(6) 2018.She went on to develop a medial malleolar fracture nonunion, post-traumatic arthropathy and varus ankle deformity.She was taken to the operating room on (b)(6) 2018 and underwent a tibiotalocalcaneal fusion with a stryker t2 ankle arthrodesis nail (10x200mm).She developed clinical and radiographic consolidation of her fusion site 149 days post-operatively.At her last follow-up appointment on (b)(6) 2019 there were findings of partial backout and loosening of her calcaneal screw.The plan at this time is to retain her implants with possible removal in the future if she becomes symptomatic.¿.

• 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; DE D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10305559
• MDR Text Key: 203169416
• Report Number: 0009610622-2020-00364
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/24/2020
• 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 Age: 61 YR