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

Catalog Number 72205138

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during surgery, healicoil anchors collapsed during screwing despite being introduced perpendicularly.The procedure was completed with a significant delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

A3: information received.B4: event description updated.Internal complaint reference: case (b)(4).

Event Description

It was reported that, during a rotator cuff repair surgery, healicoil anchor curled up on themselve during screwing despite being introduced perpendicularly.The procedure was completed with a significant delay using a back-up device in a different bone hole.No further complications reported.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review for the reported batch number concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A review of the material found there are requirements for conformance and a certificate of material analysis is required.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.Note: complaint 1 of 2.Reference (b)(4) (mdr 1219602-2021-01115) for 2nd device.

Event Description

It was reported that, during a rotator cuff repair surgery, two helicoil anchors curled up on themselves during screwing despite being introduced perpendicularly.The procedure was completed with a significant delay using a back-up device in the same bone hole.No patient injury or other complications were reported.

• Brand Name: HEALICOIL KNOTLESS PK ST
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11822831
• MDR Text Key: 250613517
• Report Number: 1219602-2021-01116
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767351
• UDI-Public: 885556767351
• Combination Product (y/n): N
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 72205138
• Device Lot Number: 50887742
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR