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

Catalog Number	7210424
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during shoulder procedure the accu-pass was not rolled in the device.It was found external to the patient.No delay and a back up was available to complete the procedure.No patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: one 7210424 accu-pass str shuttle 45 deg right curve used in treatment, has been returned for evaluation.The information provided states that ¿during shoulder procedure the accu-pass was not rolled in the device¿.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.In addition, a corrective action has been initiated to investigate this failure.

• 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: 10054724
• Report Number: 1219602-2020-00781
• Device Sequence Number: 11458827
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 3596010534453
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 09/04/2022
• Device Catalogue Number: 7210424
• Device Lot Number: 2040027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1