|
Catalog Number 400.834.04S |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/11/2023 |
Event Type
malfunction
|
Event Description
|
Device report from synthes reports an event in china as follows: it was reported on (b)(6) 2023 that during the surgery, the screw was broken,and all the pieces were removed from the patient.Another device was used to complete the surgery.There were no adverse consequences for the patient.No additional information could be provided.This report is for one (1) cranial-scr plusdrive ø1.6 self-drill l4.This is report 1 of 1 for complaint pc-(b)(4).
|
|
Manufacturer Narrative
|
H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E1:(b)(6).H3, h6: 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.
|
|
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.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 cranial-scr plusdrive ø1.6 self-drill l4 was broken from the distal tip, fragment was not returned.According to the surgical technique guide, these devices can break during use (when subjected to excessive forces or outside the recommended surgical technique).While no root cause can be determined for the reported issue, the breakage condition of the implant was consistent with a random component failure that may have been caused by exposure to unintended forces during insertion process.The most likely cause was implantation into hard bone requiring the application of significant torque to insert the screw.A dimensional inspection for the cranial-scr plusdrive ø1.6 self-drill l4 was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the cranial-scr plusdrive ø1.6 self-drill l4 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.If information is obtained that was not available for this 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.H6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device image.Visual analysis of the photo revealed that there was no damage or defects with the cranial-scr plusdrive ø1.6 self-drill l4.The allegation cannot be confirmed with the photo 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 not confirmed as the cranial-scr plusdrive ø1.6 self-drill l4 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.H4, h6: device history record (dhr) review conducted: part #: 400.834.04s, lot #: 2605p70, manufacturing site: jabil bettlach, release to warehouse date: 21, october 2022, expiry date: 01, october 2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.H3, h6: the subject device has been 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.
|
|
Search Alerts/Recalls
|
|
|