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OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM/3.0MM CONNECTING CLAMP; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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| Catalog Number 395.133 |
| Device Problems
Device-Device Incompatibility (2919); Unintended Movement (3026)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, while performing a review of the falange minifixer system, it was evident that the system bars did not enter the patella properly.The system is blocked for operation due to incomplete key pieces.No further information provided.Concomitant devices reported: 3.0mm/3.0mm connecting clamp (part# 395.133, lot# unknown, quantity# 2), holding clamp 1.25mm (part# 395.125, lot# unknown, quantity# 2), holding clamp 1.6mm (part# 395.126, lot# unknown, quantity# 1).This is report 1 of 5 for (b)(4).
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Event Description
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Concomitant devices reported: 3.0mm/3.0mm connecting clamp (part 395.133, lot l594154, l234175, l344165, l234175, 8577693, quantity 5), holding clamp 1.25mm (part 395.125, lot l639570, l671743 (x2), l716619, 1358912, l805743, quantity 6), holding clamp 1.6mm (part 395.126, lot 1362940 (x2), l082894, l1362940, l858755, l797231 (x2), quantity 7).This is report 1 of 10 for (b)(4).Additional devices for this event are captured on related complaints (b)(4).
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Manufacturer Narrative
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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.D10: complainant part is not expected to be returned for manufacturer review/investigation.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.
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Manufacturer Narrative
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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, h6: part: 395.133.Lot: l234175.Manufacturing site: hägendorf.Release to warehouse date: 23.Feb.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: connec-clamp ø3 f/mini-ext-fix (part# 395.133, lot# l234175, qty# 1) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the device looks good without any damage.Functional testing: functional testing of the device received was not performed at cq as the mating devices were not returned at cq.Can the complaint be replicated with the returned device(s)? unable to perform dimensional inspection: a dimensional inspection was not performed at cq due to the geometry of the device and no visual defects were evident with the device returned.Document/specification review: the following drawings were reviewed during the investigation: connect clamp.No design issues or discrepancies were noticed.Complaint confirmed? no.Investigation conclusion: the complaint condition cannot be confirmed for the connec-clamp ø3 f/mini-ext-fix (part# 395.133, lot# l234175).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 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.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.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.
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Manufacturer Narrative
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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.H10 additional narrative: updated data: d4, h4.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.Corrected data: d9, h3, h6.
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Manufacturer Narrative
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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, h4, h6: connec-clamp ø3 f/mini-ext-fix (part# 395.133, lot# l234175, qty# (b)(4) ) 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# l234175).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: l234175, manufacturing site: hägendorf, release to warehouse date: 23.Feb.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.
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