Catalog Number 39-RD-0060 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that a procedure was performed in the dominican republic on (b)(6) 2024, utilizing the reform pedicle screw system.Upon attempts to final tighten the lock screw, the tip of the t25 lock screw torque driver, reform (39-rd-0060) broke.The broken piece was removed and verification was performed to assure no pieces remained.The procedure was completed utilizing other instruments readily available.There was no patient injury but there was a delay of seven (7) minutes due to the reported malfunction.
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Manufacturer Narrative
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H3 device evaluation - although the information provided indicates the product is available for return, it has yet to be received.Without the opportunity to examine the complaint product, no conclusions can be drawn.Review of device history records found thirty-two (32) pieces of lot 00959up released for distribution on (b)(6) 2022 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.Should the complaint product be received, a follow-up medwatch report will be submitted.
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Manufacturer Narrative
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H3 device evaluation - the driver was returned with a fracture of the tip.The fracture plane is skewed relative to the driver's longitudinal axis.This is indicative of parts failing under combination loading.It is believed that bending moments were applied in combination with torque which led to this failure.The part has likely seen extensive use since being fabricated in 2022 so this failure may have been initiated during prior usage.It is unclear if a counter torque wrench was being used during set screw tightening.Proper use of a counter torque wrench helps mitigate bending moments acting on the driver's tip.No corrective actions are being recommended.
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Event Description
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It was reported that a procedure was performed in the dominican republic on (b)(6) 2024, utilizing the reform pedicle screw system.Upon attempts to final tighten the lock screw, the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken piece was removed and verification was performed to assure no pieces remained.The procedure was completed utilizing other instrumentation readily available.There was no patient injury but there was a delay of seven (7) minutes due to the reported malfunctions.
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Search Alerts/Recalls
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