MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Numbness (2415)

Event Date 01/01/2006

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), which was published on 10 september 2009.The title of this study is ¿the use of a retrograde fixed-angle intramedullary nail for tibiocalcaneal arthrodesis after severe loss of the talus¿ and is associated with the stryker t2 ankle arthrodesis nailing system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2006 and 2007.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 3 complaints were initiated retrospectively for the different adverse event mentioned in the report.This product inquiry addresses infection.The study states: ¿one patient (patient 6), despite negative intra-operative microbiologic cultures, had a recurrence of infection.This patient had total loss of his talus following repeated surgery and had undergone screw fixation of the tibionavicular and the calcaneocuboid sites additionally, and a peroneus brevis flap.With recurrence of infection, the fixation implants were removed at 1 year post-fusion, and the sinus tract excised and the wound debrided.At that time the fusion site had healed.Five episodes of debridement were needed to obtain a clean wound and the defect was covered with a split-skin graft.There was no evidence of recurrence of infection subsequently, but this patient had numbness of the toes and recurrent metatarsalgia on prolonged weight-bearing.¿.

• Brand Name: UNKNOWN SCREW
• 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: 8548952
• MDR Text Key: 143054198
• Report Number: 0009610622-2019-00226
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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: 04/15/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR