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	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arcr procedure, the filament came out of the wheel and it could not be advanced at all.The procedure was successfully completed without delay using a s&n 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
H10 h3, h6: the reported accu-pass str shuttle 45 deg lft curve device used for treatment was not returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.The information provided states: ¿during an arcr procedure, the filament came out of the wheel and it could not be advanced at all¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include improper use of device.The instruction for use 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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H2, h3, h6: one 7210423 accu-pass str shuttle 45 deg lft curve used in treatment was returned for evaluation.Visual assessment confirms the complaint.The information provided states that ¿during an arcr procedure, the filament came out of the wheel and it could not be advanced at all¿.Visual assessment showed a cut monofilament.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include improper use of device.The instruction for use 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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Complaint history review indicated no similar allegations for the lot number reported.A review of the batch records was performed which confirmed no abnormalities were reported with this lot during manufacture.

• 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: 10376281
• Report Number: 1219602-2020-01184
• Device Sequence Number: 3001094
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 12/14/2020
• Device Model Number: 7210423
• Device Catalogue Number: 7210423
• Device Lot Number: 50702764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/08/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/03/2020; 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1