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OBERDORF SYNTHES PRODUKTIONS GMBH HOLDING CLAMP 1.6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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| Catalog Number 395.126 |
| 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 3 of 5 for (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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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 3 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.H3, h4, h6: part: 395.126, lo: l289716, manufacturing site: hägendorf, release to warehouse date: 15 march 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the holding clamp ø1.6 f/mini-ext-fix (p/n: 395.126, lot number: l289716) was received at us customer quality (cq).Visual inspection of the complaint device showed no damage or defects with the device.Functional test: complete functional testing of the device received was not performed at cq as the mating devices were not returned at cq.But all the components of the device were disassembled and assembled as intended without any issues.Can the complaint be replicated with the returned device(s)? unable to perform.Dimensional inspection: dimensional inspection of the connecting rod hole in the clamp was performed at cq.The diameter of the hole of the clamp was measured to be within specification as per the drawing.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as no defects were identified and a full functional test could not be performed.No definitive root cause could be determined based on the provided information.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.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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