DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 25; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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Model Number 2274-25-500 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 drill bit broke due to hard bone.There was no surgical delay.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Manufacturer Narrative
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Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and visual: cracked were reviewed.It was determined visual: cracked has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2020 ¿ aug 21, 2023.In total, there have been zero serious injuries and zero deaths reports related to visual: cracked in the last 3.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, visual: cracked associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.
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