MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER CABLE-READY CABLE GRIP TENSIONER; TRAUMA INSTRUMENT

Catalog Number 00223200500

Device Problem Mechanical Jam (2983)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the tensioner had a knob that would not turn.

Manufacturer Narrative

The device history record for the cable tensioner was reviewed for deviations and/or anomalies with no deviations or anomalies identified.A 1.8mm cable passed freely through the inside diameter of the tensioner with the cam unlocked.It held tension up to 100lbs, then released.The tensioner body turns freely.Release button was checked and performed as intended.The stated event could not be replicated.This device is used for treatment.Initial product history search conducted on october 12, 2016 revealed no additional complaints against the related part and lot combinations.The alleged failure mode could not be replicated.A definitive root cause for the release button of the tensioner being very hard to push cannot be determined.

• Brand Name: ZIMMER CABLE-READY CABLE GRIP TENSIONER
• Type of Device: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5854597
• MDR Text Key: 51404473
• Report Number: 0001822565-2016-02729
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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: 63107352
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1