MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7210424
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a labrum repair surgery, when the dr.Was using the "accupass, 45°, right" to pass the suture for the repair, the monofilament would not winded completely through making it unable to be used.The procedure was successfully completed using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h2, h3, h6: the reported 45 degree right accu-pass suture shuttle, used 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.From the information provided, the monofilament would not pass properly.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: blockage of the needle not allowing the monofilament to pass.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H3, h6: two 7210424 accu-pass str shuttle 45 deg right curve used in treatment, have been returned for evaluation.The information provided states that ¿during a labrum repair surgery, when the dr.Was using the "accupass, 45, right" to pass the suture for the repair, the monofilament would not winded completely through making it unable to be used¿.Visual assessment confirms the complaint.The rollers were stuck and difficult to roll.The monofilament was tangled.An exact root cause cannot be determined with confidence; however factors that could have contributed to the reported event include, excessive force.Instructions for use confirms instructions, recommendations and precautionary statements for proper use of product.Per instructions for use: ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in failure of the instrument.¿ rolling the wheels forward and backward may initiate tangling or wrapping of the monofilament around the wheels.The roller wheels perform best with continuous movement in the same direction.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.The product family is under review.Occurrence rate of allegations are monitored via surveillance.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10308163
• Report Number: 1219602-2020-01107
• Device Sequence Number: 860585
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 03596010534453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: 7210424
• Device Catalogue Number: 7210424
• Device Lot Number: 2049522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 10/05/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/07/2020; 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1