MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203378
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff suture process, the healicoil sa pk 4.5mm anchor fell off after being implanted.The anchor did not fell off in the patient.The procedure was completed with a smith and nephew back up device using the original drilled bone hole, using a anchor matching instrument to prepare the insertion site and leaving no void in the patient.There was a delay less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The sutures are still run through the anchor but have been pulled out of the device's cannula.The anchor is on the device and has been fractured.Bio debris is present.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 tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, off-axis insertion, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: corrected data on h6 (investigation findings) & h8.

• Brand Name: HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23741441
• Report Number: 1219602-2025-03120
• Device Sequence Number: 8413141
• Product Code: MBI
• UDI-Device Identifier: 03596010657862
• UDI-Public: 3596010657862
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 72203378
• Device Lot Number: 2149919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2024
• 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 Sex: Unknown