MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE HEALICOIL RG SA 4.75MM W/2 UB-BL,CBRD BL

Model Number 72203704

Device Problems Break (1069); Device Issue (2379)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

During a rotator cuff repair procedure utilizing a healicoil rg sa 4.75mm w/2 ub-bl,cbrd bl, it was reported that the sutures pulled through on two anchors.The eyelets on both implants broke, causing the sutures to pull through and come away from the anchors.The implants were left in the patient without the sutures; and fixation was not achieved.The anchors inserted flawlessly and no damage was noted on the sutures.One site was prepped with a 3.8 awl and the other site was prepped with a hcr 4.75 tap.The surgeon completed the procedure with a knotless repair using two fiber tapes and two swivel locks.Patient's condition was reported as okay.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.(b)(4).

• Brand Name: HEALICOIL RG SA 4.75MM W/2 UB-BL,CBRD BL
• Type of Device: HEALICOIL RG SA 4.75MM W/2 UB-BL,CBRD BL
• Manufacturer (Section D): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3884705
• MDR Text Key: 4539707
• Report Number: 1219602-2014-00181
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2017
• Device Model Number: 72203704
• Device Catalogue Number: 72203704
• Device Lot Number: 50491374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2014
• Device Age: 4 MO
• Event Location: Ambulatory Surgical Facility
• Date Manufacturer Received: 05/13/2014
• Date Device Manufactured: 02/07/2014
• 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