MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS RG ST; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72205136
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy and acl, the specialist placed a helicoil knotless regenesorb anchor.As a post to give more stability to the graft.However the initiators indicated for the placement of this type of implants were unavailable, so the specialist used his own technique to place the implant.At the moment of performing the respective blocking of the implant, it fractured, leaving less than half of the implant outside.The specialist considered that there was no need to place an additional implant because the graft was stable.The procedure was completed using the same reported device.There was no surgical delay.No further complications were reported.
Event or Problem Description
It was reported that during a knee arthroscopy and acl, the specialist placed a helicoil knotless regenesorb anchor.As a post to give more stability to the graft.However the initiators indicated for the placement of this type of implants were unavailable, so the specialist used his own technique to place the implant.At the moment of performing the respective blocking of the implant, it fractured, leaving less than half of the implant outside.The half of the anchor was removed from the patient with a clamp.The specialist considered that there was no need to place an additional implant because the graft was stable.The procedure was completed using the same reported device.There was no surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the implant being inserted into the patient, and it shows a noticeable fracture along its length.A review of device records showed 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.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 review of the polymer specifications found that the storage conditions and material requirements are specified for the implant material.Each lot must be accompanied by a material certificate of analysis.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks, leading to unintended consequences, and rough handling or excessive force to the device.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during a knee arthroscopy and acl, the specialist placed a helicoil knotless regenesorb anchor.As a post to give more stability to the graft.However the initiators indicated for the placement of this type of implants were unavailable, so the specialist used his own technique to place the implant.At the moment of performing the respective blocking of the implant, it fractured, leaving less than half of the implant outside.The half of the anchor was removed from the patient with a clamp.The specialist considered that there was no need to place an additional implant because the graft was stable.The procedure was completed using the same reported device.There was no surgical delay.No further complications were reported.Patient current status is stable.

• Brand Name: HEALICOIL KNOTLESS RG ST
• 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: 19968556
• Report Number: 1219602-2024-01726
• Device Sequence Number: 8962033
• Product Code: MAI
• UDI-Device Identifier: 00885556767320
• UDI-Public: 885556767320
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K193558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72205136
• Device Lot Number: 51191100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/14/2024; 09/06/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/21/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2024
• 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
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 65 KG