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

Catalog Number 298.801.01S

Device Problem Sticking (1597)

Patient Problem Sedation (2368)

Event Type  Injury  

Manufacturer Narrative

Manufacturer alert date was 01september2015.Device was not received by the manufacturer.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.Complaint is an adverse event and product problem.Device was broken during insertion; device was not implanted/explanted.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

This report is for user facility medwatch number 1601530000-2015-0002.The only information contained in this report is correction or additional information.It was reported the complained event caused an hour delay obtaining another company's tensioner device.That device worked appropriately and the surgery was a success.There was no patient harm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(4): a service and repair evaluation was preformed: the customer reported the tensioner got stuck and the cable could not be removed.The vendor repaired the item, which will be returned to the customer upon completion of service and repair process.The cable, part# 298.801.01s, was not repairable and discarded during the repair of the tensioner.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 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5117705
• MDR Text Key: 27262805
• Report Number: 2520274-2015-16375
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• PMA/PMN Number: PK992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 298.801.01S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1