WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH
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Model Number 319.006 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2021 |
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) 2021, the tip of depth gauge broke off from the main body.It was unknown when the damage happened.It was unknown if there was any patient involvement.There were no patient consequences are reported.This complaint involves three (3) devices.This report is for (1) depth gauge for 2.0mm and 2.4mm screws this report is 2 of 3 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Telephone: (b)(6).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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.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.H10 additional narrative: h6 - codes updated to imdrf codes.Visual inspection: the depth gauge f/scr ø2+2.4 meas-range up-t (p/n: 319.006, lot #: ft00054) was returned for analysis.Visual inspection of the returned device found a broken condition, the needle broke off from the instrument.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Complaint confirmed: yes, complaint can be confirmed based on the available information.Investigation conclusion: the reported condition of the complaint device (the depth gauge f/scr ø2+2.4 meas-range up-t) is confirmed.Device is broken.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.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 # 319.006 synthes lot#: ft00054 supplier lot # ft00054 release to warehouse date: 07 oct 2016 supplier: flextronics america llc nr-00520000 was generated during dhr review because the lot number on the certificate of compliance was incorrect.The lot number on all other paperwork and the etch on the part is ft00054.This non-conformance is not relevant to the complaint condition since the nc is related to the certificate of compliance paperwork was incorrect.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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