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

Catalog Number 611.105.01S

Device Problem Break (1069)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Udi# (b)(4).Incident occurred intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number (b)(6).Device history records (dhr) review was completed for sterile part# 611.105.01s, lot# 9844265.Non-sterile part# 611.105.01, lot# p231585.Manufacturing location: (b)(4), manufacturing date: feb 26, 2016, expiry date: feb 01, 2026.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 europe reports an event in (b)(6) as follows: it was reporter that on (b)(6) 2016, during the surgery, the cerclage cable broke.No surgical delay was reported.Patient outcome was not reported.This report is for one (1) 1.7mm cocr cable with ti crimp 750mm - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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

It was reporter that on (b)(6) 2017, during the surgery, the cerclage cable broke.

• Brand Name: 1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE
• 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: 6633969
• MDR Text Key: 77646844
• Report Number: 3000270450-2017-10194
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

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: Physician
• Device Catalogue Number: 611.105.01S
• Device Lot Number: 9844265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 08/03/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1