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

Model Number 72203704

Device Problem Device Issue (2379)

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

Event Date 02/26/2014

Event Type  malfunction  

Event Description

During a shoulder scope utilizing the healicoil rg sa 4.75mm w/2 ub-bl, cbrd bl, it was reported that the anchor pulled out when the doctor was tying the suture.The case was completed with a 6.5mm twinfix ha in a new hole.The hole that was intended for the 4.75mm anchor was left empty with no device.The patient¿s bone quality was reported as ¿eggshell¿ with a cortical layer only and 3-7 mm of mushy, porous bone beneath (patient is mid to late sixties).Good visualization was maintained throughout the procedure.

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 01850 ; 9787491561
• MDR Report Key: 3685555
• MDR Text Key: 4237959
• Report Number: 1219602-2014-00074
• 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: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 72203704
• Device Catalogue Number: 72203704
• Device Lot Number: 50481421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2014
• Device Age: 4 MO
• Event Location: Ambulatory Surgical Facility
• Date Manufacturer Received: 02/26/2014
• Date Device Manufactured: 11/05/2013
• 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