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); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference : (b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair of the right shoulder, the healicoil regenasorb 4.75 anchor was placed with ultrabraid prepped with a dilator, the sutures were passed through the cuff and were tied down.When tightening the knots in the sutures the healicoil came out of the bone, it did not hold and the anchor was broken in half down one side.It was removed from the patient along with the suture.The procedure was abandoned.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 a3 and b5: updated.
Event or Problem Description
It was reported that during a rotator cuff repair of the right shoulder, the healicoil regenasorb 4.75 anchor was placed with ultrabraid prepped with a dilator, the sutures were passed through the cuff and were tied down.When tightening the knots in the sutures the healicoil came out of the bone, it did not hold and the anchor was broken in half down one side.It was removed from the patient along with the suture arthroscopically with a hand instrument.A dilator was used to prep the insertion site.The procedure was abandoned.No further complications were reported.
Additional Manufacturer Narrative
A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during a rotator cuff repair of the right shoulder, the healicoil regenesorb 4.75 anchor was placed with ultrabraid suture prepped with a dilator, the sutures were passed through the cuff and were tied down.When tightening the knots in the sutures the healicoil came out of the bone, it did not hold and the anchor was broken in half down one side.It was removed from the patient along with the suture arthroscopically with a hand instrument.The procedure was abandoned.No further complications were reported.

• 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: 18357349
• Report Number: 1219602-2023-02484
• Device Sequence Number: 12456303
• Product Code: MAI
• UDI-Device Identifier: 00885554030310
• UDI-Public: 00885554030310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/13/2024

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: 09/03/2026
• Device Catalogue Number: 72203704
• Device Lot Number: 2130196
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 02/08/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 12/20/2023; 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2023
• 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: Female