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

Model Number	7210425
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the monofilament would not come out of the accu-pass hence, it could not be used.The procedure was completed without delay using a s+n backup device.No patient injury or 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
One 7210425 accu-pass str shuttle 45 deg up used in treatment, has been returned for evaluation.Visual assessment confirms complaint.Monofilament would not advance through accu-pass.An exact root cause cannot be determined with confidence; however factors that could have contributed to the reported event include, excessive force.Ifu confirms instructions, recommendations and precautionary statements for proper use of product.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.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG UP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10212262
• Report Number: 1219602-2020-00964
• Device Sequence Number: 14054594
• Product Code: LXH
• UDI-Device Identifier: 03596010534460
• UDI-Public: 03596010534460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/15/2020

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: 09/01/2022
• Device Model Number: 7210425
• Device Catalogue Number: 7210425
• Device Lot Number: 2040029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1