MAUDE Adverse Event Report: ZIMMER INC STATAK SOFT TISSUE ANCHOR; JDR

Catalog Number 00234407200

Device Problem Failure To Adhere Or Bond (1031)

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 the string came loose on the anchor assembly.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Product was not returned for review and the complaint could not be verified.The complaint information was forwarded to the supplier further evaluation.The supplier could not verify the reported issue.Review of the device history record found no abnormalities that would contribute to the reported issue.It was stated that the anchor should fit into the tube and move freely, the sutures should not be tangled.This device is used for treatment.A complaint history search found there were no additional complaints for this lot number part number combination.With the information available a definitive root cause cannot be concluded.

• Brand Name: STATAK SOFT TISSUE ANCHOR
• Type of Device: JDR
• 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: 5135145
• MDR Text Key: 28151526
• Report Number: 1822565-2015-02088
• Device Sequence Number: 1
• Product Code: JDR
• 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: Followup,Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00234407200
• Device Lot Number: 492685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2013
• 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