Model Number 63-SP-9005 |
Device Problem
Break (1069)
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Patient Problem
Laceration(s) (1946)
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Event Date 07/01/2022 |
Event Type
Injury
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Event Description
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It was reported that a procedure was performed on (b)(6) 2022, utilizing the surelok mis 3l pedicle screw system.While attempting to insert the second rod, the tip of the cl rod inserter (63-sp-9005) broke.The doctor had to make a larger wiltse incision, and the broken piece was removed with forceps and the rod was inserted using a rod inserter pulled from another instrument tray.There was no patient injury reported, but a fifteen-minute (15) delay due to the malfunction of the rod inserter.
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Manufacturer Narrative
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Reporter occupation: sales representative.Type of reportable event - serious injury due to the need for medical intervention in extending the incision and removing the broken inserter tip device evaluation - although information provided indicates that the product is available for evaluation, it has not yet been returned.Should the product be received, a follow-up medwatch report will be filed upon completion of the investigation.No conclusions as to the cause of the breakage can be drawn at this time.Review of device history records found that twenty-six (26) pieces of lot 00116pt-r release for distribution on 5/30/2019 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are recommended.
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Manufacturer Narrative
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Device evaluation - the inserter was returned for evaluation without the distal fractured tip.The laser markings are crisp and legible and the gold knob freely turns, driving the center shaft in and out.The condition of the fracture location is in agreement with the results concluded in testing in which the inserter is overloaded to 160 in-lbs.No corrective action is recommended at this time due to the likelihood the failure can be attributed to an excessive load (torque) applied to the instrument.
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Event Description
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It was reported that a procedure was performed on (b)(6) 2022, utilizing the surelok mis 3l pedicle screw system.While attempting to insert the second rod, the tip of the cl rod inserter (63-sp-9005) broke.The doctor had to make a larger wiltse incision, and the broken piece was removed with forceps and the rod was inserted using a rod inserter pulled from another instrument tray.There was no patient injury reported, but a fifteen-minute (15) delay due to the malfunction of the rod inserter.
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Search Alerts/Recalls
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