MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/2 UB-BL, CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203379
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair, the surgeon prepared the insertion site of the healicoil anchor with a golden awl.After inserting the tip of the anchor, 3-5mm from the tip cracked and broke off.The surgeon removed the anchor and pieces without modifying the original bone hole.The procedure was completed with non-significant surgical delay using a back-up device in the original bone hole.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in original packaging.The sutures are still run from the anchor, through the cannula, and tied at the cleat on the handle.The anchor is broken and missing threads.A functional evaluation could not be performed on a damaged single use 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 raw material strength and storage requirements are specified and each lot must be accompanied by a material certificate of analysis.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include use of excessive force during insertion, this can cause failure of the suture anchor or insertion device.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL SA PK 5.5MM 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17821668
• Report Number: 1219602-2023-01879
• Device Sequence Number: 14063493
• Product Code: MBI
• UDI-Device Identifier: 00885554026306
• UDI-Public: 00885554026306
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 72203379
• Device Lot Number: 2105913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• 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