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

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference : (b)(4).

Event 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.

Manufacturer Narrative

Internal complaint reference (b)(4).H10 a3 and b5: updated.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 330932502
• Report Number: 1219602-2023-02484
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554030310
• UDI-Public: 00885554030310
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 72203704
• Device Lot Number: 2130196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female