MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 4.75MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203704
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, a small part of the thread of the helicoil anchor broke when inserting the anchor into the patient.The procedure was completed with a smith and nephew back up device.There was a delay less than 30 minutes and no further complications were reported.
Event or Problem Description
It was reported that during an arthroscopy, a small part of the thread of the helicoil anchor broke when inserting the anchor into the patient.The procedure was completed with a smith and nephew back up device using the original drilled bone hole, no void left in the patient.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed it was not returned with any original packaging.The sutures were not returned.The anchor is still on the device.The distal end of the anchor has been compressed and deformed but not broken.Bio debris is present.A functional evaluation was performed on the returned device and found the anchor will deploy from the insertion device.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 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 material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.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 and leading to unintended consequences.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.

• Brand Name: HEALICOIL RG SA 4.75MM W/2 UB-BL CBRD 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: 19840455
• Report Number: 1219602-2024-01611
• Device Sequence Number: 12732146
• Product Code: MAI
• UDI-Device Identifier: 00885554030310
• UDI-Public: 00885554030310
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151105
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

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 Expiration Date: 02/08/2026
• Device Catalogue Number: 72203704
• Device Lot Number: 2109764
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/04/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/05/2024; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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 Sex: Unknown