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
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Muscle/Tendon Damage (4532)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after a surgery was performed on (b)(6) 2022 in which a healicoil anchor was implanted, the patient experienced popping in and out of the device.This adverse event was treated by a revision surgery on (b)(6) 2023, in which the healicoil anchor was exchanged.Patient's current health status is unknown.
Event or Problem Description
It was reported that on 22-nov-2020 a left shoulder rotator cuff repair, distal clavicle excision, extensive debridement, biceps tenodesis, and subacromial decompression were performed, where a healicoil was placed.In december 2022, the patient felt a pop when doing therapy and developed severe pain and noticed that his bicep had sunken into his arm.On january 19, a revision surgery was performed and it was discovered that the smith & nephew anchor(s) failed, which caused a high-grade cuff tear among other serious complications.Surgeon removed the failed hardware and placed two q-fix implants.An extensive debridement of the scar tissue where he had stiffness was made.The central aspect of the medial row anchor had pulled out and a broken cuff anchor had to be removed, as well as the loose anchor debris.Then, an additional lateral row anchor for additional footprint coverage and stability was placed.The current status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the provided images were reviewed but are of poor quality and do not aid in the investigation.It should be noted the ifu indicates, ¿as in all suture anchor or suturing techniques, until biological attachment of tissue to bone is complete the fixation should be considered temporary and may not withstand weight bearing or other unsupported stresses.The suture anchor and suture are not intended to provide indefinite biomechanical integrity.¿ the reported, stiff shoulder may be consistent with the intraoperative finding of scar tissue.Scar tissue is a known complication of surgery and is associated with the surgical procedures.With the information provided the clinical root cause of the reported biceps tenodesis rupture, and high-grade partial tear cannot be definitively concluded; however, the revision report notes portion of the medial aspect of the cuff had not healed, the patients¿ prior history of extensive shoulder injury and/or weight bearing and body stresses on the appliance, prior to healing of the medial aspect of the cuff, cannot be ruled out as possible contributing factors.The patient impact beyond the reported events cannot be determined.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.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 RG SA 5.5MM W/3 UB-BL CB BL BK
• 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: 16616744
• Report Number: 1219602-2023-00421
• Device Sequence Number: 5131979
• Product Code: MAI
• UDI-Device Identifier: 00885554030860
• UDI-Public: 00885554030860
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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 Model Number: 72203707
• Device Catalogue Number: 72203707
• Device Lot Number: UNKNOWN
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 03/26/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other; Required Intervention
• Patient Sex: Unknown