MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE FIXATION

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to remove hardware after x-rays revealed that the helical blade had migrated thru the femoral head.During the revision surgery an unknown trochanteric fixation nail, helical blade and distal locking screw were removed.In addition a 1.7mm implanted cable wire broke during the revision and part of the wire remains implanted in the patient.Intraoperative x-rays were performed related to the cable wire breaking.The procedure was successfully completed with no surgical delay.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient id information unknown.This report is for 1 unknown cable wire/unknown lot number.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4513939
• MDR Text Key: 5494379
• Report Number: 2520274-2015-10925
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention