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Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for an unknown locking screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2020, during fixation of olecranon, the stardrive screwdriver shaft t8 55mm and torque limiting attachment would not provide appropriate tightening feedback on variable angle locking screws.The surgeon used non tla screwdriver for final tightening.There was a surgical delay of 2 minutes.Procedure was successfully completed.Patient status as planned.Concomitant devices reported: torque limiting attachment 1.2nm (part # 03.110.002, lot # 1008217, quantity 1), stardrive screwdriver shaft t8 55mm (part # 314.453, lot # 3172926, quantity 1).This report is for 1 unknown locking screw.This is report 2 of 6 for (b)(4).
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Search Alerts/Recalls
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