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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 09/12/2022 |
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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment (img_1341).Visual analysis of the photo revealed that the depth gauge for 2.0mm and 2.4mm screws appears to be broken from the needle, fragment is not visible in the evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for depth gauge for 2.0mm and 2.4mm screws.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 number:319.006.Synthes lot number: ft00086.Supplier lot number: n/a.Release to warehouse date: (b)(6) 2016.Expiration date: n/a.Supplier: flextronics america llc.No ncrs were generated during production.Note: dhr information was retrieved from pi-16082314078850530 as it is the same lot number.Device history batch null device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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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Event Description
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It was reported that on (b)(6) 2022, the below items were found to be damaged in spd at the hospital.T15 cannulated screw driver had twisted tip.2.0/2.4mm depth gauge tip was broken.4mm hex cannulated screw driver had a defect in the rubber of the handle.The items were set aside in spd of the hospital for repair/replace.There was no patient consequence.This complaint involves three (3) devices.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws this is report 2 of 3 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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 needle of the depth gauge for 2.0mm and 2.4mm screws has broken, the broken needle was not retuned.No other issues were observed.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.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 condition of the depth gauge for 2.0mm and 2.4mm screws would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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