MAUDE Adverse Event Report: SYNTHES SELZACH 1.7MM CABLE WITH CRIMP 750MM; CERCLAGE FIXATION

Catalog Number 298.801.01

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Udi# (b)(4).Incident occurred intraoperatively.Device was not implanted/explanted.Reporter contact number (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, a single wire has loosened intraoperatively from cerclage cable.No patient harm reported.Procedure was completed successfully.Reportedly, surgery was delayed for unknown length of time.This report is for one (1) 1.7mm cable with crimp 750mm this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A customer quality evaluation was performed for the subject device (cercl-cable w/crimp ø1.7 sst, part number 298.801.01, lot number unknown).The subject device was returned with the complaint condition stating: our investigation has shown that there several wire broken and the whole cerclage cable is dissolved.As the lot number is unknown we are not able to research the device history record and the manufacturing documents.Unfortunately, as no detailed clinical information is available, we are not able to determine the cause which has lead to this circumstance.We can only assume that there was a complication during operation, the cable could not resist the applied force which finally led to the material overload / fatigue failure.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance's.We can only assume that there was a complication during operation, the cable could not resist the applied force which finally led to the material overload / fatigue failure.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
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6842808
• MDR Text Key: 85776163
• Report Number: 3000270450-2017-10316
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: 298.801.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1