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| Model Number |
395.125 |
| Medical Device Problem Code |
Device-Device Incompatibility (2919)
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| Health Effect - Clinical Code |
No Patient Involvement (2645)
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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Additional code: ktt.Reporter is company representative, investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history: part number: 395.125, lot number: 1358912, manufacturing site: (b)(4), release to warehouse date: 09 june 2005.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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Event or Problem Description
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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.No patient involvement.This is report 1 of 10 for (b)(4).This complaint is linked to (b)(4).
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Additional 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: h3, h6: a product investigation was conducted.Visual inspection: holding clamp ø1.25 f/mini-ext-fix (part# 395.125, lot# 1358912, 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.Functional testing: 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.The complaint replication with the returned device(s) was 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 intended to be measuring from 3.00mm to 3.05mm and it was measured to be 3.01mm which is within specification as per the drawing d0003525 rev.00 document/specification review: the relevant drawings were reviewed during the investigation: no design issues or discrepancies were noticed.Investigation conclusion: the complaint condition cannot be confirmed for the holding clamp ø1.25 f/mini-ext-fix (part# 395.125, lot# 1358912).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.
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Additional 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.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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Additional Manufacturer Narrative
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Product complaint # (b)(4).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, 4, h6: device history lot part number: 395.125, lot number: 1358912, manufacturing site: hägendorf, release to warehouse date: 09.June 2005.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: background: 04/06/2020: updated event description: performing a review of the falange minifixer system, it is evident that the system bars do not enter the patella properly.For now, the system is blocked for operation due to incomplete key pieces.395.133 * (b)(4) units, 395.125 * (b)(4)units, 395.126 * (b)(4) units.This complaint involves (b)(4) devices.Investigation flow: functional.Visual inspection: holding clamp ø1.25 f/mini-ext-fix (part# 395.125, lot# 1358912, 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.Functional testing: 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: (gauge pins: gp29/ gp32) dimensional inspection of the connecting rod hole in the clamp was performed at cq.The diameter of the hole of the clamp was measured and is within specification.Document/specification review: complaint was not confirmed.Investigation conclusion the complaint condition cannot be confirmed for the holding clamp ø1.25 f/mini-ext-fix (part# 395.125, lot# 1358912).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.
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Search Alerts/Recalls
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