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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure using an accu-pass 45-degree, when the needle was inserted into the meniscus, the monofilament would not come out; therefore, it was not able to be used.The procedure was successfully completed without delay using a back-up 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
H3, h6 h10: one 7210425 accu-pass str shuttle 45 deg up used in treatment was returned for evaluation.The information provided states that ¿during the procedure using a accu-pass 45-degree, upbend, sterile when the needle was inserted into the meniscus, the monofilament would not come out¿.Visual assessment showed a cut monofilament.The instruction for use (ifu 1061583) was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.¿ 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.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.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 UP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10497512
• Report Number: 1219602-2020-01360
• Device Sequence Number: 2720643
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 11/14/2022
• Device Model Number: 7210425
• Device Catalogue Number: 7210425
• Device Lot Number: 2044731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1