SYNTHES GMBH 2.5MM DRILL BIT/QC/GOLD/110MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 310.250 |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the drill bit was dull during surgery.There were no consequences to the patient.No further information is available.This report involves one 2.5mm drill bit/qc/gold/110mm.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.Additional device product codes: hsz, gff, hwe.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Manufacturer Narrative
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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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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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Manufacturer Narrative
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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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: h3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that drill bit ø2.5 l110/85 2flute f/quick co was rounded and worn from the sharp edges of the flutes, dullness condition is attributed to this condition.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection, it was determined that the reusable instrument device was dullness from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed dullness condition of drill bit ø2.5 l110/85 2flute f/quick co would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part # 310.250.Lot # l660875.Manufacturing site:werk bettlach.Release to warehouse date: 04 dec 2017.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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