MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYS ADVNCD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72205205

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during surgery, the "tendon stapler" was unsuccessful on multiple occasions of picking up the tendon staples and deploying them onto the implant.The procedure was completed by changing the surgical technique with a delay greater than 30 minutes.No further 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.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 3 W ARTHRO DEL SYS ADVNCD
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10396908
• MDR Text Key: 202572822
• Report Number: 3003604053-2020-00075
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556733547
• UDI-Public: 885556733547
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2022
• Device Catalogue Number: 72205205
• Device Lot Number: A8219
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1