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 Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2020

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, when the box of the healicoil was opened, it fell off from the opposite side.The sterilization pack was not sealed from the first.It is unknown if there was a back-up device available.No delay and not patient injuries were 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.The complaint states: ¿during an unknown procedure, when the box of the healicoil was opened, it fell off from the opposite side¿.Visual assessment showed that pouch was unsealed from the bottom.Pouch showed it was sealed.An exact root cause cannot be determined with confidence.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Corrective action has been initiated.A preliminary risk assessment (pra) or health hazard evaluation (hhe) per pro-qa-109 is required to define the material disposition of the product potentially impacted will be initiated.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.

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 that pouch was unsealed from the bottom.Pouch showed seal residue.A product specification review indicated the findings were a defect.A complaint history review indicated similar allegations 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 has been initiated to mitigate future occurrence of similar events.Information corrected in h6, h7, h9 and h10.

• 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: 10273415
• MDR Text Key: 198863045
• Report Number: 1219602-2020-01031
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: 72203704
• Device Catalogue Number: 72203704
• Device Lot Number: 2039262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• 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