MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 72200419

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Event Description

It was reported that, during an unspecified surgery, the accupass suture shuttle 70° upbend did not roll the monofilament out of device.The procedure was completed, without significant delay, by using a competitor device.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported 70 degree accu-pass suture shuttle, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.However, a trend of this nature has been observed with this product line in the field, prompting a corrective action investigation.As a result of the investigation the following actions were implemented.(1) the bend test was updated, including testing to evaluate the force required to move the monofilament in the accu-pass devices providing a quantitative value in order to remove the human element in the acceptance or rejection of the parts.(2) the ultrasonic welder was re-qualified to include new parameters.A review of the complaint and manufacturing records was performed which confirmed the reported device lots in question were manufactured prior to these changes.Further investigation is not warranted at this time.

• Brand Name: ACCU-PASS SUTURE SHUTTLE 70 DEGREE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9531075
• MDR Text Key: 174181058
• Report Number: 1219602-2019-01675
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010542397
• UDI-Public: 03596010542397
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200419
• Device Catalogue Number: 72200419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1