MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2T NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Insufficient Information (3190)

Patient Problems Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 01/13/2012

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Product was disposed.

Event Description

A patient had injury on (b)(6) 2011 and took external fixation on (b)(4).Then the patient took t2t surgical on (b)(64) 2012.After surgery, drain observed from the affected part.Debridement and washing did on (b)(6) and give antibiotic.On (b)(6) 2012 the patient left the hospital.On (b)(6) 2013, a nail was removed.A culture test of the nail was positive.On (b)(6) 2013 the patient left the hospital.

Manufacturer Narrative

Investigation revealed the subject product to be a concomitant item.The device did not contribute to the event.

Event Description

A patient had injury on (b)(6) 2011 and took external fixation on (b)(6).Then the patient took t2t surgical on (b)(6) 2012.After surgery, drain observed from the affected part.Debridement and washing did on (b)(6) and give antibiotic.On (b)(6) 2012 the patient left the hospital.On (b)(6) 2013, a nail was removed.A culture test of the nail was positive.On (b)(6) 2013 the patient left the hospital.

• Brand Name: UNKNOWN T2T 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: 5512223
• MDR Text Key: 40731648
• Report Number: 0009610622-2016-00134
• Device Sequence Number: 1
• Product Code: JDS
• 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,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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: 02/19/2016
• 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