MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72203705

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/06/2020

Event Type  malfunction  

Event Description

It was reported that, during a procedure, the edges of the packaging for a healicoil rsb 4.75mm anchor, were not sealed correctly when opened in theater.The item was found to be unsterile and could not be used.There was a backup device available.No significant delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72203705 healicoil regenesorb 4.75mm suture anchor device intended for use in treatment, was not returned for evaluation.Ifu 10601233 contains recommendations and precautionary statements for proper use of product.Due to unavailability, visual evaluation was impossible.Excessive forces applied to the instrument can result in failure.This also applies to transit and storage situations.Complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A product specification review indicated that missing seals is a defect.A complaint history review indicated a similar allegation for the lot number reported.A 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 was previously initiated to mitigate similar events.

• Brand Name: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10471909
• MDR Text Key: 204937925
• Report Number: 1219602-2020-01333
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554031409
• UDI-Public: 00885554031409
• Combination Product (y/n): N
• PMA/PMN Number: K123393
• 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: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Catalogue Number: 72203705
• Device Lot Number: 2048390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Removal/Correction Number: Z-0136-2021
• Patient Sequence Number: 1