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

Catalog Number	72203697
Medical Device Problem Codes	Difficult to Insert (1316); Nonstandard Device (1420)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a rotator cuff repair, it was noticed that the healicoil regenesorb wire was too thin in places and did not pass through the cuff automatically with the tweezer, due to this event an additional bone hole was required.Surgery was resumed, after a non-significant delay, with a back-up device in the additional bone hole.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.This case reports that during placement of the healicoil anchor the suture failed to pass through the cuff.It is unknown if the anchor was removed from the patient.Per case details an additional bone hole was required.Based on the limited information provided the root cause of the reported issue cannot be determined.The healicoil anchor is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further risk to the patient is anticipated as a result of the additional bone hole.No further clinical/medical assessment is warranted at this time.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL
• Common Device Name: 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: 14830900
• Report Number: 1219602-2022-00914
• Device Sequence Number: 2380342
• Product Code: MAI
• UDI-Device Identifier: 00885554031393
• UDI-Public: 885554031393
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2024
• Device Catalogue Number: 72203697
• Device Lot Number: 2074205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/05/2022
• Date Device Manufactured: 06/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown