MAUDE Adverse Event Report: PIVOT MEDICAL CINCHLOCK SS KNOTLESS ANCHOR; SUTURE ANCHOR

Catalog Number CAT02462

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

The surgeon placed the anchor in bone hole.While tensioning the suture to approximate the labrum to the bone, the suture detached from the anchor.He left the anchor in the bone but removed the suture from the patient and discarded it.The anchor allegedly remains in the patient.There was no injury reported.Additional anchors were placed to complete the repair, with no incident.There was no surgical delay as a result of the device incident.

Manufacturer Narrative

The anchor remains implanted in the patient's bone; therefore, it will not be returned.A definitive cause of the event could not be determined from the information available and without the device for evaluation.Based upon feedback from the surgeon, the likely root cause of the incident was due to the surgeon placing tension and counter-tension on both suture limbs, which caused the suture to cut through the anchor.The device history record was reviewed and shows that the lot for the device allegedly at issue met manufacturer specifications and release criteria.This was determined to be a reportable event due to the permanent nature of the anchor that was left in the patient, even though there was no injury reported.

• Brand Name: CINCHLOCK SS KNOTLESS ANCHOR
• Type of Device: SUTURE ANCHOR
• Manufacturer (Section D): PIVOT MEDICAL; 247 humboldt ct; sunnyvale CA 94089
• Manufacturer Contact: jon cook ; 247 humboldt ct; sunnyvale, CA 94089 ; 4087741452
• MDR Report Key: 3822929
• MDR Text Key: 4394532
• Report Number: 3007210693-2014-00001
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: CAT02462
• Device Lot Number: 13121101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1