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

Model Number 72203707

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

H10 h3, h6: the reported healicoil rg sa 5.5mm w/3 ub-bl cb bl bk was returned for evaluation.The complaint states: ¿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¿.Visual assessment showed crimp around seal.The device returned was not opened.An exact root cause cannot be determined with confidence, however; factors that may affect device performance include device storage or transportation for extended periods of time in extremely high or low temperature altering the composition of materials.Controlled environment procedures are being followed in order to best mitigate risk.Based upon the volume of product manufactured through the controlled environment, the product return represents a low occurrence rate.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints batch records was performed, no other complaints of this failure was found.Further investigation is not warranted at this time.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Visual assessment showed crimp around seal.The device returned was not opened.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.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.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 10342033
• MDR Text Key: 201000459
• Report Number: 1219602-2020-01154
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554030860
• UDI-Public: 00885554030860
• 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: 11/21/2022
• Device Model Number: 72203707
• Device Catalogue Number: 72203707
• Device Lot Number: 2045872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• 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