MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN_KIE_PRODUCT; IMPLANT

Catalog Number UNK_KIE

Device Problem Difficult to Insert (1316)

Patient Problem Hip Fracture (2349)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

Device will not be returned as it remains implanted.Catalog number is unknown at this time.The device was reported as an unknown 13mm nail.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

On (b)(6) 2015, t2 scn surgery for the condylar fracture after tka (other company product) was performed.During the surgery, refracture was occurred when the surgeon was inserting the nail.After that, dall-miles was used and the fracture was fixed.

• Brand Name: UNKNOWN_KIE_PRODUCT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5346421
• MDR Text Key: 35161247
• Report Number: 0009610622-2016-00004
• 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
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• 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