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

Catalog Number 4403

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 08/17/2020

Event Type  Injury  

Event Description

It was reported that during a revision rcr using regeneten implant the nurse have difficulty capturing tendon anchors from puck.On the retrival 3 tendon anchors broke while trying to load them.The anchors snapped before being removed from the puck.The distal tip of inserter was slightly skewed after initial use.Then a second bone anchor was opened to spare the tendon anchor puck, it was used a new inserter and the tendor anchors broke again when loading.The surgeon use the remaining anchors 1-2 short of his preference, and the needle and suture in order to finish securing the implant.A delay of 5 minutes were reported.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

H10 h3,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 prior to use, inspect the device to ensure it is not damaged.Do not use a damaged 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.

• 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: 10524489
• MDR Text Key: 206999647
• Report Number: 3003604053-2020-00102
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00854501006159
• UDI-Public: 854501006159
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4403
• Device Lot Number: 2044104
• 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