SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Model Number 7210424 |
Device Problem
Failure to Eject (4010)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that, during a labrum repair surgery, when the dr.Was using the "accupass, 45°, right" to pass the suture for the repair, the monofilament would not winded completely through making it unable to be used.The procedure was successfully completed using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10, h2, h3, h6: the reported 45 degree right accu-pass suture shuttle, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the monofilament would not pass properly.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: blockage of the needle not allowing the monofilament to pass.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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Manufacturer Narrative
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H3, h6: two 7210424 accu-pass str shuttle 45 deg right curve used in treatment, have been returned for evaluation.The information provided states that ¿during a labrum repair surgery, when the dr.Was using the "accupass, 45, right" to pass the suture for the repair, the monofilament would not winded completely through making it unable to be used¿.Visual assessment confirms the complaint.The rollers were stuck and difficult to roll.The monofilament was tangled.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.
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