Model Number 37-HP-0400 |
Device Problems
Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Patient information - unknown.Occupation - other; distributor.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 2 of 2 mdrs filed for the same event reference 3005739886-2015-00038.
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Event Description
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During acdf surgery performed in (b)(6) on (b)(6) 2020, the surgeon was using the angled screw driver (37-hp-0400 lot 0143it-r) to insert the screw as the angle was difficult to use the straight driver.While he was using the angled driver a sound popped from the driver and it stopped rotating smoothly.A second fixed angle driver (37-hp-0400 lot 0056itr) was attempted to be used but it was not holding the screw, as he was trying to insert the screw in the hole it was detaching from the screw driver.Bone wax was attempted to be used on the tip but was unsuccessful.There was no injury to the patient but a 1-1/2 hour delay to the procedure as a result of the reported issues.
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Manufacturer Narrative
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H2 device evaluation: engineering performed a visual inspection of the complaint product.There is no visible damage or deformity of the driver tip.Engineering was unable to reproduce the reported failure with mating parts.Instrument was inspected upon return from the field and no issues were found.Review of device history records found twenty-two (22) pieces were released for distribution with no deviation or anomalies.Complaint history review did not reveal a trend for reports of this nature for this part number.As a definite root cause could not be identified and there was not a trend for reports of this nature identified, the need for corrective action is not indicated.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2015-00038-1/00039-1).
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Event Description
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During acdf surgery performed in dubai, uae on (b)(6) 2020, the surgeon was using the angled screw driver (37-hp-0400 lot 0143it-r) to insert the screw as the angle was difficult to use the straight driver.While he was using the angled driver a sound popped from the driver and it stopped rotating smoothly.A second fixed angle driver (37-hp-0400 lot 0056itr) was attempted to be used but it was not holding the screw, as he was trying to insert the screw in the hole it was detaching from the screw driver.Bone wax was attempted to be used on the tip but was unsuccessful.There was no injury to the patient but a 1-1/2 hour delay to the procedure as a result of the reported issues.
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Search Alerts/Recalls
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