MAUDE Adverse Event Report: SYNTHES (USA) 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Catalog Number 298.801.01S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age and weight were not available for reporting.Other number¿udi: (b)(4)expiration date unknown(10)lot number unknown.The subject device was not implanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a periprosthetic proximal femur revision surgery, for a fracture femur below the hip stem, the 1.7mm cable got bound up and stuck in the cable tensioner because of the slack in the tensioner.The tensioner would not tighten properly.The tensioner and cable remained stuck together and were sent to sterile processing.Devices were implanted during this procedure and no devices were explanted.There was a surgical delay of two minutes due to the reported event.The procedure was successfully completed with the patient in stable condition.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

The original awareness date for the reported event was populated as june 15, 2016 in error on the initial medwatch.The actual awareness date for the event was june 14, 2016.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5755711
• MDR Text Key: 48351555
• Report Number: 2520274-2016-13313
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 298.801.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/26/2016
• 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