MAUDE Adverse Event Report: SYNTHES MONUMENT CABLE CUTTER-STANDARD; CUTTER,WIRE

Catalog Number 391.905

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Concomitant device: therapy date reported as (b)(6) 2016.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part # 391.905 lot # a7ia49 synthes lot # 4049506 no ncr's 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.Release to warehouse date: 3 jan 2000.Supplier: (b)(6).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 the cable cutter broke during removal of a 3.5 synapse rod on (b)(6), 2017.The hardware was originally implanted in (b)(6) 2016 and was removed from the c1-c2 level due to bursitis.There was no reported issue with the synapse rod.A piece of the cable cutter jaw broke off while using the cable cutter to cut the synapse rod.The broken piece was retrieved.Another available cable cutter was used to successfully complete the surgery with no delay.The patient outcome was as expected and patient was reported as stable.Hardware removal due to bursitis is addressed in (b)(4).This report addresses the cable cutter breakage.Concomitant device reported: 3.5 synapse rod (part number unknown, lot number unknown, quantity 1).This report is for one (1) cable cutter-standard.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: this complaint is confirmed.A section of one of the carbide inserts/distal cutting jaws has sheared off and is missing.The portion that is missing is approximately 5mm x 2mm.Whether this complaint can be replicated is not applicable for this condition as the returned device is already broken.Per the technique guide, the returned cable cutter-standard is a reusable instrument available in the sternal zipfix system and spine cable system.In the spine cable system, the cable cutter is intended to be used to cut the leader portions off of the double lead cable implants.In the sternal zipfix system, the cable cutter is intended to be used to cut the needle portion off of the sternal zipfix implants.The complaint condition was most likely caused by using the cable cutters to cut a depuy 5.5mm ti rod (part 1797-62-300), when it is designed to cut the leader portions off of synthes double lead cable implants and also the needle portion off of synthes sternal zipfix implants.No new malfunctions were identified as a result of the investigation.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed for the returned device as part of this investigation.The relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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.

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

Additional information was received on june 30, 2017 with further reporting that the surgeon was using cable cutters to cut and shorten a depuy 5.5mm ti rod (part # 1797-62-300).The surgeon held the rod over the sterile table, attempting to cut the rod when the cable cutter broke.There were no fragments from the broken cable cutter.The broken piece from the cable cutter was retrieved and the rod was not affected.There was no patient impact.It was noted that the incorrect cable cutters were used.The surgeon obtained the correct cutter designed to cut rods.The surgeon cut the rod for the purpose of making it shorter.It is unknown if any additional hardware was added.Only one rod was shortened.The rest of the depuy hardware remained intact.The hardware was originally implanted in (b)(6) 2016 and was removed from the c1-c2 level due to bursitis.The surgeon completed the procedure successfully and the patient was reported as stable.Concomitant device reported: depuy 5.5mm ti rod (part # 1797-62-300, lot # unknown, quantity of 1).

• Brand Name: CABLE CUTTER-STANDARD
• Type of Device: CUTTER,WIRE
• 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: 6680351
• MDR Text Key: 78908072
• Report Number: 1719045-2017-10617
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982198396
• UDI-Public: (01)10886982198396(10)A7IA49
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 06/06/2017

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: 391.905
• Device Lot Number: A7IA49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 06/30/2017; 07/13/2017
• Supplement Dates FDA Received: 07/10/2017; 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 81