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

Model Number	7210423
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during arthroscopy procedure, the monofilament was came out of the wheel and it could not be advanced at all.A backup device was available to complete the procedure with no significant delay or other complication reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H11: further assessment of information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that no harm nor injury was reported and no previous injury or harm has been confirmed to be caused by the device in the past, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10140148
• Report Number: 1219602-2020-00882
• Device Sequence Number: 13978557
• Product Code: LXH
• UDI-Device Identifier: 03596010534446
• UDI-Public: 03596010534446
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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 Model Number: 7210423
• Device Catalogue Number: 7210423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1