Model Number TKL SPDBRG IMP SYS W/ BC SWVLK & NDL |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure is an internal manufacturing process issue.
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Event Description
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On 12/13/2021, it was reported by a sales representative via e-mail that a ar-2600sbs-10 speed bridge disengaged.This occurred on (b)(6) 2021 during a procedure when the handle of the disposable punch disengaged from the metal spear during insertion to create a hole for the anterior medial anchor.The spear was removed using vice grips since the handle spun independently off the metal shaft.The case was completed using a reusable punch from an in house shoulder tray.There was no patient effect reported.Additional information requested.Additional information provided on 12/14/2021 : the case was completed using a standard silver punch from the shoulder tray.The bone quality of the patient was above-average.Additional information provided on 12/14/2021 : a rotator cuff repair was being performed.
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Search Alerts/Recalls
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