|
Catalog Number 04.043.140S |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/15/2022 |
Event Type
malfunction
|
Event Description
|
Device report from synthes reports an event in united kingdom as follows: it was reported on (b)(6) 2022, that during insertion of the nail the reaming rod became caught behind the proximal polymer at the junction with the most distal locking hole, this resulted in the polymer becoming distorted.The nail was removed and the damaged part of the polymer was removed with a clip through the locking hole and the nail then reintroduced.Significant delay in surgery as a solution was worked out.There is no indication that the time delay occurred at a critical procedure step where high risks to the patient may be present.There is no indication that the delay resulted in any impact to the expected surgical outcome.This report is for one (1) tibial nail advanced ø9 l360.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional product code: jds.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Mfr site: (b)(4).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.
|
|
Event Description
|
This is report 1 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device photo.Visual analysis of the photo revealed that there was no damage or defects with the tibial nail advanced ø9 l360.The complaint cannot be confirmed with 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 not confirmed as the tibial nail advanced ø9 l360 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.D4,h4,h6: device history record (dhr) review: part #: 04.043.140s.Lot #: 235p476.Manufacturing site: jabil bettlach.Release to warehouse date: 05, august 2021.Expiry date: 01, july 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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.
|
|
Search Alerts/Recalls
|
|
|