MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 72205307

Device Problem Material Fragmentation (1261)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that during a shoulder arthroscopy, the bioinductive implant began to disintegrate in the joint of the patient; the surgeon removed as much frayed tissue on the implant as possible using a werewolf wand.The surgeon had ample time to deliver the tendon anchors and bone anchors within the right timeframe.The procedure was completed using the same reported device.There was a delay of less than 30 minutes, and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a shoulder arthroscopy, the bioinductive implant began to fray along the border in the joint of the patient; the surgeon removed as much frayed tissue on the implant as possible, nearly 50% of it, using a werewolf wand.The surgeon had ample time to deliver the tendon anchors and bone anchors within the right timeframe.The procedure was completed using the same reported device.There was a delay of less than 30 minutes, and no further complications were reported.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: 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 no 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 implant specifications found that the staple pull through strength and tensile strength requirements are specified, and a certificate of compliance is required.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.

• Brand Name: BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG
• 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: 18432326
• MDR Text Key: 331928166
• Report Number: 3003604053-2024-00001
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00885556745038
• UDI-Public: 885556745038
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K140300
• 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,Followup
• Report Date: 02/21/2024

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: 72205307
• Device Lot Number: 2081252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/02/2024; 02/16/2024
• Supplement Dates FDA Received: 01/16/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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