|
Catalog Number 03.133.006 |
Device Problems
Material Deformation (2976); Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.Date of event: only the event year is known.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.
|
|
Event Description
|
Device report from synthes reports an event in the united kingdom as follows: it was reported that on an unknown date, the kit was opened during surgery, and while drilling, the end became bent.There was unexpected wear as this was a relatively new set.This report involves one 2.7mm non-locking drill guide.This is report 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
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.Part # 03.133.006; synthes lot # h891750; supplier lot # h891750; release to warehouse date # 01 aug 2020; supplier # (b)(4).No non-conformance reports were generated during production.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
|
|
Manufacturer Narrative
|
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: h3, h6 part # 03.133.006 synthes lot # h891750 supplier lot # h891750 release to warehouse date # 01 aug 2020 supplier # viant upland llc no non-conformance reports were generated during production.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 the 2.0 mm guide was deformed, as well as stripped.No other problems identified.The observed condition was consistent as an end of life indicator for the device.No other issues where identified.After a visual inspection per guidance provided in windchill document , it was determined that the reusable instrument device was worn 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 condition of non-locking drill guide 2.7, p/n 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.Drawing/specifications reviewed: the following document was reviewed: ver a.2 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.D9.
|
|
Search Alerts/Recalls
|
|
|