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 that when the rental instrument team checked the instrument, the knob would not turn.

Manufacturer Narrative

(b)(4).As returned, the cam lever of both devices was stiff and difficult to actuate.After applying lubricant the levers functioned as intended.Both devices accepted a 1.8mm cable and tensioned to (b)(4) lbs.The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.This device is used for treatment.The package insert included with the instrument has instructions for use, warnings, and precautions for these instruments.Some of these instructions are "lubricate threads with a commercial and water based lubricant (such as instrument milk) to reduce friction and wear." the tensioners functioned as intended upon lubrication, with the components moving freely.No product issue has been identified.

• 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: 5440875
• MDR Text Key: 38314455
• Report Number: 1822565-2016-00307
• 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: 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: 63032416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2015
• 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