MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72203707

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 03/02/2018

Event Type  malfunction  

Event Description

It was reported that after one week from primary arcr operation, it was confirmed that the anchor came off from the site.Therefore, revision surgery was performed immediately.The condition of retrieved anchor was soft.The anchor was different from the original form.A competitor device was use in this revision surgery.

Manufacturer Narrative

Per new information received we did not know the lot number of this device, please do not take the information of this sections into account.

Manufacturer Narrative

Additional information.Correction.

Manufacturer Narrative

One 5.5mm rg sa healicoil anchor was returned for evaluation.The anchor was broken into several pieces.The anchor did not feel soft to the touch as described in the complaint and could not be differentiated by feel from the standard anchor.Product testing is not possible due to the condition of the anchor.After receiving the lot information for the complaint product a further evaluation was conducted.No product was left in inventory to pull and test.Molded anchor component retains were identified and tested.A material analysis on the component retains from the same batches was performed and their molecular weights were found to be normal.Based on this further review there is no indication that there was a manufacturing issue that could have caused premature degradation of the anchor.

• Brand Name: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7405325
• MDR Text Key: 104703902
• Report Number: 1219602-2018-00417
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Catalogue Number: 72203707
• Device Lot Number: 50692469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 05/21/2018; 06/20/2018; 08/07/2018
• Supplement Dates FDA Received: 06/20/2018; 06/23/2018; 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 77 YR