MAUDE Adverse Event Report: SYNTHES (USA)

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2013

Event Type  malfunction  

Event Description

It was reported that a cable tensioner got stuck during surgery.The cable was being used during a joint-bipolar hip case and jammed in the tensioner.The surgeon had to cut the cable to release it from the patient.The cable was still in the tensioner.The surgeon was able to do that easily without additional intervention.There was a 10 minute delay in the procedure.There was no harm to the patient and the case concluded as planned successfully.This report is for an unknown cable.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

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 product is entering the complaint system.Patient id reported as (b)(6).Actual weight reported as (b)(6) kg.This report is for unknown cable/unknown lot.Device was not implanted/explanted.Device was used for treatment, not diagnosis.Placeholder.

• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: tracy gutierrez ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3601692
• MDR Text Key: 4092737
• Report Number: 2520274-2014-00374
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2013

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2013
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 69