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 Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/24/2020

Event Type  Injury  

Event Description

It was reported a revision surgery of rotator cuff repair where a bioinductive implant was involved.The exact event was not specified; however, the procedure was completed with a competitor device with no other complications.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, 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 an isolated event.A review of the instructions for use found the need for repeated surgery because tendons do not heal properly or tear again.A review of risk management files found that the reported failure was documented appropriately.Clinical evaluation found that no further medical assessment is warranted at this time.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.

Event Description

It was reported that, after having a rotator cuff repair surgery a year ago; the patient went under a revision surgery on september 2020 where a regeneten implant and competitor anchors were used due to surgeon's preference.Two weeks after they implanted regeneten device, the surgeon had to go back into the patient¿s shoulder due to a mechanical construct of the patient's rotator cuff repair that affected the regeneten implant in her shoulder.The 2nd revision surgery was successfully completed with competitor devices instead of s+n products.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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
• MDR Report Key: 10694735
• MDR Text Key: 211853192
• Report Number: 3003604053-2020-00130
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00885556745038
• UDI-Public: 885556745038
• Combination Product (y/n): N
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72205307
• Device Lot Number: A8509
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR