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 Problems Unsealed Device Packaging (1444); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2020

Event Type  Injury  

Event Description

It was reported by the doctor that the patient stated that "has pushed out three times" after going through an achilles tendon reconstruction using healicoil.No other complications were reported.It is unknown how the event was solved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported by the doctor that the patient stated that "has passed out three times" as a result of infection after going through an achilles tendon reconstruction using healicoil.No other complications were reported.I&d procedures were performed.Patient was found to be doing fine.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H11: correction on b5.

Event Description

It was reported by the doctor that the patient stated that "has push out three times" after going through an achilles tendon reconstruction using healicoil.No other complications were reported.It is unknown how the event was solved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: (b)(4).Updated d8 and h6 (clinical code, impact code and medical device problem) h3, h6: the reported device was not returned for evaluation.A review of sterilization records showed there were no indications to suggest that the product did not meet specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of historical escalations and the manufacturing process found a manufacturing issue related to an inadequate sealing process leading to sterile barrier breaches.A review of sealing process found that instructions are properly documented.All parameters must be reviewed prior the initiation of the sealing process.While sealing, the operator should seal only one pouch at a time, and all sealing pouches must be inspected in their entirety before and after the sealing process.Based on the limited information provided, the clinical root cause of the reported unspecified infection cannot be definitively concluded.It is unknown if the infection is directly related to the implant and/or improper, incomplete seal of the device packaging or hematogenous in nature.The patient impact beyond the reported unspecified infection and revision cannot be determined.A field action was implemented to mitigate risk to patient health due to possible improper/incomplete seal of the device packaging.Though the reported device was not returned for evaluation the reported event is likely to have occurred and with a probable root cause of a manufacturing failure.A field action and a corrective action have been previously initiated to mitigate this issue.

Event Description

It was reported that after an achilles tendon reconstruction on 01-sep-2020 using a healicoil anchor, the patient stated that the device "has pus¿d out three times", as in infection.There were i&d procedures performed to treat the event.Patient is doing fine on last update received.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10646123
• MDR Text Key: 210373429
• Report Number: 1219602-2020-01539
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554030860
• UDI-Public: 00885554030860
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: 72203707
• Device Catalogue Number: 72203707
• Device Lot Number: 2036696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other