MAUDE Adverse Event Report: ZIMMER INC ZIMMER CABLE-READY CABLE GRIP TENSIONER; JDQ

Catalog Number 00223200500

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the button on the tensioner was unable to be pushed to reset it.

Manufacturer Narrative

As returned, all measurements taken are conforming to print specifications.The functionality test concluded that there is a cable jammed inside of the cannulation which is hindering the functionality of the tensioner and does not allow the foregrip assembly to close flush with the handle.The button was pressed and worked.The cannulation was blocked such that no additional cable could go through and light could not be seen though the cannulation.There were scuffs and other cosmetic signs of wear on the nose end and cam lever of the tensioner indicating previous effective use.The device history records were reviewed and the records indicated the device met specifications at the time of manufacture.The cable grip tensioner had a potential field age of approximately 7 years at the time of incident with an unknown number of uses.The cable grip tensioner is used for treatment.A complaint history search found that there are no other complaints for the product lot number involved.It is stated in the follow-up e-mails that the tensioner was used with no issues, then did not work the next day when the button was pressed.The likely root cause of the tensioner not functioning properly is the cable fragment in the device.

• Brand Name: ZIMMER CABLE-READY CABLE GRIP TENSIONER
• 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: 5443941
• MDR Text Key: 38458318
• Report Number: 1822565-2016-00322
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

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 Catalogue Number: 00223200500
• Device Lot Number: 61111174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2008
• 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