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

Catalog Number 611.105.01S

Device Problem Mechanical Jam (2983)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to intra-operative issues, the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).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.Device was 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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during a femoral peri-implant fracture surgery on (b)(6) 2016, the surgeon had difficult with a cable and a tensioner.The surgeon used a tensioner and put tension onto the cerclage cable.Then he temporarily completed the fixation, but he could not detach the cable from the tensioner.He tried to separate them several times, but was unable to, so he cut the cable.The surgeon did not have any difficulty with a second cable.The surgery was extended for ten minutes.Concomitant part: tensioner (part unknown, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Device was 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 COCR CABLE WITH TI CRIMP 750MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6087301
• MDR Text Key: 59459280
• Report Number: 2520274-2016-15288
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

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: 611.105.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2016
• 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
• Treatment: 1 UNKNOWN TENSIONER
• Patient Age: 67 YR
• Patient Weight: 67