MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYSTEM; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 72205200

Device Problems No Apparent Adverse Event (3189); Separation Problem (4043)

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

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a procedure that involved the use of a arthro bioindctive implant 1 large and a bone anchors 3 w arthro del system, the doctor wanted to use the regeneten implant to augment his rotator cuff repair to enhance the quality of the repair and the underlying tendon.The initial loading of the first large implant was very difficult the loading device could not be removed easily and took a lot of strength from the surgeon to remove, then the implants were deployed without any issues and all the tendon staples went in fine, seven tendon staples were put in and went to remove the delivery device, the surgeon dropped his hand towards the arm and pulled gently, instead of releasing the implant it pulled it out with the delivery device, and it was stuck to the delivery device the surgeon had to use quite a bit of force to pull it out, the doctor did not feel the implant was in good enough condition to proceed another attempt was made.As the surgeon did not want to perform a mini-open to use the implant he left the cuff repair without the regeneten augment.This caused a delay of less than 30 minutes.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.**note: the arthro bioindctive implant 1 large is reported in report (b)(4).

Manufacturer Narrative

H6: 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 concluded this was a repeat issue.A review of the instructions for use 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 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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Additional information received has confirmed there was no failure of the tendon staples, they pulled out along with the implant when the delivery device was being removed.As such no staples were left in the patient and no medical intervention was required.This issue will not contribute to serious injury.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Event Description

It was reported that patient had a rotator cuff repair surgery.The primary cuff was repaired using a double row arthroscopic technique.The surgeon used two(2) healicoil pk anchors medially and two(2) multifix s anchors laterally.Additionally, the doctor wanted to use the regeneten implant to augment the quality of the repair and the underlying tendon.The initial loading of the first large implant was very difficult as the loading device could not be removed easily and took a lot of strength from the surgeon to remove.Then, the implants were deployed without any issues and all the tendon staples went in fine, seven tendon staples were put in.However, when the surgeon was going to remove the delivery device, the surgeon dropped his hand towards the arm and pulled gently, instead of releasing the implant it pulled it out with the delivery device and the tendon staples.The exact same thing happened again with the next delivery device.As the surgeon did not want to perform a mini-open to use the implant, he decided not to use the regeneten implant.This caused a delay of less than 30 minutes.No other complications were reported.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11448315
• MDR Text Key: 238836911
• Report Number: 3003604053-2021-00076
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00885556733479
• UDI-Public: 885556733479
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 72205200
• Device Lot Number: A8410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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): Required Intervention