MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203697
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, when the healicoil anchor was being inserted into the bone it broke.The procedure was completed with 5 minutes delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(6).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 through the implant, down the cannula, out the handle, and tied to the cleat.The implant in on the insertion tool.The top three ribs/threads of the implant are broken and were not returned, the tip of the implant is broken off and caught between the sutures and the tip of the device.A functional evaluation could not be performed due to the condition the device was received in.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include unintended excessive force on insertion or off-axial insertion.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h6: codes updated.

• Brand Name: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB 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: 17770519
• Report Number: 1219602-2023-01794
• Device Sequence Number: 7073351
• Product Code: MAI
• UDI-Device Identifier: 00885554031393
• UDI-Public: 885554031393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2024

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
• Device Expiration Date: 04/13/2026
• Device Catalogue Number: 72203697
• Device Lot Number: 2117529
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 01/04/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 01/09/2024; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown