Catalog Number 395.133 |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Additional device product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is company representative.A device history record (dhr) review was conducted: part: 395.133, lot: l344165, manufacturing site: (b)(4), release to warehouse date: 17.May.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
|
Device report from synthes reports an event in (b)(6) as follows: it was reported during an inspection of the minifixer system, it is noted that the holding and connecting clamps do not function appropriately with the other devices.The system bars does not enter the patella properly.There was no patient involvement reported.This report is for one (1) 3.0mm/3.0mm connecting clamp.This is report 1 of 3 for complaint (b)(4).Additional devices are reported under linked complaints (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.H3, h4, h6- connec-clamp ø3 f/mini-ext-fix (part# 395.133, lot# l344165, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device looks good without any damage.The complaint condition cannot be confirmed for the connec-clamp ø3 f/mini-ext-fix (part# 395.133, lot# l344165).A definitive root cause for the reported problem cannot be determined.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot : part: 395.133.Lot: l344165.Manufacturing site: hägendorf.Release to warehouse date: 17.May.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were 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.
|
|
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.H3, h6: the 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
|
|