MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 4.75MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72203704

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2020

Event Type  malfunction  

Event Description

It was reported that during inspection in the hospital, when the healicoil package was opened to be checked, a crimp failure was found in a part of the sterile pouch, it was not properly sealed.No case reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 72203704 healicoil rg sa 4.75mm w/2 ub-bl cbrd bl used in treatment, was returned for evaluation.Smith and nephew instructs return of product as sold when an observance is noted.The product was received in as sold condition with exception of the pouch seal.Missing or compromised packaging seals are not the intended condition for distribution.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation, although this product was part of a previous quarantine for a systemic absent seal issue.The failure was found post partial lots released to distribution.A general evaluation for absent seals was conducted across product codes.This lot was manufactured during that timeframe and were captured on the affected product list.Additional recent and further field actions were extended across the family.

Manufacturer Narrative

Information corrected in h6, h7, and h9.

• Brand Name: HEALICOIL RG SA 4.75MM W/2 UB-BL CBRD BL
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10342023
• MDR Text Key: 201000398
• Report Number: 1219602-2020-01153
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554030310
• UDI-Public: 00885554030310
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: 72203704
• Device Catalogue Number: 72203704
• Device Lot Number: 2034425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0136-2021
• Patient Sequence Number: 1