MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203984
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopic procedure, the threads of the 'healicoil' anchor seemed to be missing on insertion.The procedure was successfully completed with no delay using a backup device.A picture provided shows half of the anchor threads seemed to be broken and some sort of reddish zones like biomatter debris.No further complications were reported.
Additional Manufacturer Narrative
Health effect - impact code was updated.H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection found the device was returned without original packaging with the suture and anchor in their initial position.The anchor had 4 threads missing on one side of the anchor.Inspection under microscope found biomatter throughout the length of the threads and found uneven shear patterns on each of the eight faces where the threads were missing, indicating a breakage.An analysis of the customer provided image shows a broken anchor.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that may have contributed to the reported event include unintended excessive force on insertion or off-axial insertion.Our clinical investigation concluded: a clinical evaluation found the patient impact beyond the reported is not anticipated as it was noted per case correspondence ¿the patient is recovering from the surgery and has no unexpected implications from the product failure.¿ however, it has not been reported whether the missing threads were retrieved.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 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 no 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.A review of the anchor material drawing found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.Based on the condition of the product material found during visual inspection, additional material testing is not required.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, 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: 14251787
• Report Number: 1219602-2022-00613
• Device Sequence Number: 17397170
• Product Code: MBI
• UDI-Device Identifier: 00885554032116
• UDI-Public: 00885554032116
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 09/11/2024
• Device Model Number: 72203984
• Device Catalogue Number: 72203984
• Device Lot Number: 2041420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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