MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS WITH ARTHROSCOPIC DELIVERY; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 4403

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/14/2020

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair with regeneten, three bone anchors seemed to not line up with the punch, causing the implants to broke during insertion.All pieces were removed from the patient with a grasper.The procedure was successfully completed without significant delay using a back-up device in a different spot.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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 concluded this was a repeat issue.A review of the instructions for use found excessive force applied during anchor deployment may result in damage to the tissue, to the material being fixated, or to the anchor.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.

• Brand Name: BONE ANCHORS WITH ARTHROSCOPIC DELIVERY
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10514715
• MDR Text Key: 206329957
• Report Number: 3003604053-2020-00099
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K131635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Catalogue Number: 4403
• Device Lot Number: 2054766
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention