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

Catalog Number 00234407200

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported that the anchor was not functioning properly.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report is being amended to reflect changes.This report will be amended when our investigation is complete.(b)(4).

Manufacturer Narrative

As returned, the anchor was outside of the driver tip.After reinstalling the anchor into the driver tip, the anchor spins freely as though the hex feature is missing in the driver tip.Event information and the product received was forwarded to the device supplier, who stated the complaint was not verified, as visual examination of the returned device could not confirm the reported problem.The supplier also noted that manufacturing records were reviewed, finding the product met print specifications upon release, with no non-conformances noted.It was stated, "the anchor should fit into the tube and sutures should not be tangled and the anchor should move freely." the anchors are used for treatment.A complaint history search found no additional complaints for this part/lot number combination.The supplier concluded in their investigation that "root cause could be attributed, as follows: 1) upon removing the product from the conmed packaging, if the anchor is tapped, it could dislodge from the tube or, 2) the driver tube plug (which tightens the suture/anchor in the tube's id) may not have been tight enough.Good clinical practice would include testing/inspection of all surgical devices preoperatively to ensure proper performance." requests to the supplier for additional information resulted in the statement that no additional information can be added to the evaluation, and the device was no longer available.With the information provided, 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: 5025471
• MDR Text Key: 24548455
• Report Number: 1822565-2015-01512
• 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: Other
• Type of Report: Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 00234407200
• Device Lot Number: 604659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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