MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72203706

Device Problem Unsealed Device Packaging (1444)

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

Event Date 07/17/2020

Event Type  malfunction  

Event Description

It was reported that during the surgery it was reported that the packaging was opened, as the device was no longer sterile it was not used.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72203706 healicoil regenesorb 5.5mm suture anchor intended for use in treatment, was returned.The foil pouch was open on the straight seal edge.There was no evidence of a previous seal whatsoever as clearly seen with the side edges.If it had been sealed, there would be visible confirmation.Having a missing seal is not the intended condition for our distribution.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.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 quarantine for a systemic absent seal issue.The failure was found post partial lot release to distribution.A general evaluation for absent seals was conducted across product codes.This lot was manufactured during that timeframe and was captured on the affected product list.No additional actions required at this time.Quarantine actions are now complete.Occurrences are currently being monitored by surveillance.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Visual assessment showed the foil pouch was open on the straight seal edge.There was no evidence of a previous seal whatsoever as clearly seen with the side edges.If it had been sealed, there would be visible confirmation.A product specification review indicated the findings were a defect.A 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 quarantine for a systemic absent seal issue identified post partial lot release.The complaint was confirmed, and the root cause was determined to be a manufacturing error.A corrective action has been initiated to mitigate future recurrence of similar events.Information corrected in d9, h6, h7, h9 and h10.

• Brand Name: HEALICOIL RG SA 5.5MM 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: 10342008
• MDR Text Key: 201000392
• Report Number: 1219602-2020-01152
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• 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: 10/18/2021

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: 01/15/2023
• Device Model Number: 72203706
• Device Catalogue Number: 72203706
• Device Lot Number: 2048395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0136-2021
• Patient Sequence Number: 1