MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS RGNST; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72205135

Device Problem Break (1069)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arcr procedure, the healicoil knotless anchor was broken.The procedure was successfully completed with a surgical delay of 5 minutes using a back-up device.No further complications were reported.

Manufacturer Narrative

H2: additional information ¿b5, h6¿ h3, h6: part of the reported device was returned for evaluation.There was no relationship found between the device and the reported event.A visual evaluation showed that the device was not returned in any of its original packaging.The distal tip, distal plug, and the anchor were not returned.There is bio matter on the outer shaft assembly.A functional evaluation showed that both the plug and anchor insertion controls performed as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A review of the anchor specifications found there is a required testing of percentages of the composition and required storage instructions.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Based on the condition of the product material found during visual inspection, additional material testing is not required.Per the complaint details, all pieces of the broken healicoil knotless anchor were removed from inside of the patient.Based on the information provided, the surgeon completed the procedure with a void left in the patient, with delay of 5 minutes using a back-up device.No other complications were reported.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.The complaint was not confirmed and the root cause could not be determined since the reported broken anchor was not returned for evaluation.Factors that may have contributed to the reported event include not maintaining inserter alignment throughout insertion to ensure implant integrity.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during an arcr procedure, the healicoil knotless anchor broke.The broken pieces were removed.The procedure was successfully completed with a surgical delay of 5 minutes using a back-up device.No further complications were reported.

• Brand Name: HEALICOIL KNOTLESS RGNST
• Type of Device: 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: 14956761
• MDR Text Key: 295492669
• Report Number: 1219602-2022-00981
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767146
• UDI-Public: 885556767146
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205135
• Device Lot Number: 51023261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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 Outcome(s): Other