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

Catalog Number 298.801.01S

Device Problem Mechanical Jam (2983)

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

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was not implanted or explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing location: (b)(4).Manufacturing date: 18-jan-2017.Expiration date: 31-oct-2021.Part #: 298.801.01s, lot#: p242593 (sterile) - 1.7mm cable with crimp 750mm -sterile.Quantity 240.Inspection sheet for incoming final inspection meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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 reported that during a surgery on (b)(6) 2017 a 1.7mm cable implant became stuck in a cable tensioner.The surgery was successfully completed with a ten minute delay due to the surgeon unsuccessfully attempting to remove the cable from the tensioner.The surgeon cut away a part of the cable and discarded it during the surgery.There were no fragments generated.Surgery was completed successfully utilizing a different cable tensioner.No additional medical intervention was required.This report is for one (1) cable with crimp this is report 1 of 2 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject devices.This complaint is confirmed.A cable tensioner was received at cq with a cable stuck inside.The visible end of the cable is frayed.The gold knob on the tensioner spins freely in both directions but no longer drives tension.The complaint condition was not able to replicated at cq as the cable is stuck in the tensioner and the tensioner will not release it.No new malfunctions were identified as a result of the investigation.The returned cable and cable tensioner are devices available for use in the orthopaedic cable system with instructions for use in technique guide (relevant technique guide).A visual inspection under 5x magnification and drawing review were performed as part of this investigation.A cable tensioner was received at cq with a cable stuck inside.The visible end of the cable which is protruding from the distal end of the tensioner is frayed.The diameter of the cable was unable to be measured at cq as the visible end is frayed and the remainder is inaccessible (stuck inside tensioner).Part# 298.801.01s 1.7mm cable with crimp 750mm-sterile: drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Part#391.201 cable tensioner: drawings were reviewed during this investigation.No product design issues or discrepancies were observed.A root cause could not be determined.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6494786
• MDR Text Key: 72883312
• Report Number: 1719045-2017-10315
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 298.801.01S
• Device Lot Number: P260370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR