MAUDE Adverse Event Report: ZIMMER INC CABLE-READY CABLE CERCLAGE WITH CRIMP; JDQ

Catalog Number 00223200418

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other device used: catalog #00223200418, cable-ready cable cerclage with crimp, lot #62245203.This report will be amended when our investigation is complete.

Event Description

It is reported that as the surgeon tensioned the cables around the femur, the cables began to fray.

Manufacturer Narrative

The cable fraying and condition of the sample with the fraying of the cable leading into the crimped sleeve was consistent with what would be expected if someone were to tighten the set screw and crimp the sleeve followed by an attempt to tension the cable.Once the sleeve is crimped/crushed by the set screw it no longer allows the cable to pass freely.The complaint stated that the surgeon attempted to re-tension the cables because he thought they were not as snug and in a follow-up the surgeon indicated that he did not tension the screw before further tensioning.A potential root cause as to why the cables might have still been loose after the surgeon believed they were tense cannot be determined.As returned the two wires were cut as well as exhibited some denting and fraying.Both sleeves were crimped/crushed indicating that the set screw had been tightened down with the wire in place through the sleeve as the sleeve no longer would allow the wire to move within it.Some of the fraying of the cables suggests that the sleeve may have been crimped prior to the cables being tightened as it is not clear why a surgeon would have tightened the set screw to crimp the cable in place with the wire frayed up against the crimp mechanism.There was also debris slightly wedged into one end of the sleeve with the cable on one sample.There was fraying of the cable leading into the crimped sleeve on the other returned cable.Review of the device history records indicates the devices were manufactured and inspected to specifications.

• Brand Name: CABLE-READY CABLE CERCLAGE WITH CRIMP
• Type of Device: JDQ
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5445580
• MDR Text Key: 38884982
• Report Number: 1822565-2016-00327
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 00223200418
• Device Lot Number: 62245203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1