OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 100MM - STERILE; ROD,FIXATION,INTRAMEDULLARY
|
Back to Search Results |
|
Catalog Number 04.038.400S |
Device Problem
Break (1069)
|
Patient Problem
No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Additional product code: ktt.Occupation: synthes employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on an unknown date that the pen is broken.The procedure and the patient outcome are unknown.This is report 1 of 2 for (b)(4).
|
|
Event Description
|
Concomitant device reported: locking screw (part # 04.005.528, lot # l639562 & l636226, quantity 2).
|
|
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.Manufacturing location: elmira / monument manufacturing date: 20-mar-2018 expiration date: 01-mar-2028 part number: 04.038.400s, tfna fenestrated helical blade 100mm -sterile lot number: h556433 (sterile) lot quantity: 48 this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the tfna helical blade perf l100 tan (p/n: 04.038.400s, lot #: h556433) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that there were scratches and nicks on the threads of the device which was consistent with the explanation of the device and was not related to the complaint condition.No other issues were observed with the returned components of the device.Dimensional inspection: the dimensional inspection was performed on the returned device.- the outer diameter of the helical blade was measured to be within the specification.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed - ti tfna fenestrated helical blade complaint confirmed? no.Investigation conclusion the complaint condition is un-confirmed for the tfna helical blade perf l100 tan (p/n: 04.038.400s, lot #: h556433).There is no indication that a design or manufacturing issue has caused the issue 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.H6: patient code 3191 used to capture device failure and surgical intervention.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.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
|
The removal of the broken device required an additional operation.The procedure was successfully completed.
|
|
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.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
|
|
|