MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CINCHLOCK SS KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number CAT02462

Device Problem Cut In Material (2454)

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

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device manufacture date is not known at this time because lot number could not be confirmed however, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported the suture tape cut through the anchor.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: suture tape cut through the anchor probable root cause: "design: anchor design does not facilitate suture adjustment.Anchor barbs too aggressive for suture.Anchor does not have adequate bone engagement feature.Manufacturing: anchor not manufactured to specification.Application: excessive force applied to suture.Wrong suture type used.Removal of inserter before suture adjustment.Anchor seated too deep, suture cut".The device manufacture date is not known.(b)(4).

Event Description

It was reported the suture tape cut through the anchor.

• Brand Name: CINCHLOCK SS KNOTLESS ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6534841
• MDR Text Key: 74255131
• Report Number: 0002936485-2017-00413
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAT02462
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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