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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW ROD,FIXATION,INTRAMEDULLARY
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| Model Number 03.037.026 |
| Device Problems
Use of Device Problem (1670); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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| Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.
The investigation could not be completed; no conclusion could be drawn at the time of filing this report.
A review of the device history records has been requested.
Device was used for treatment, not diagnosis.
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Event Description
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It was reported on (b)(6) 2018, during a resident in service, while the sales consultant was putting the screw inserter into an unknown insertion handle, something was bent.
The devices were not connecting easily.
There was no patient involvement.
This complaint involves two (2) devices.
This report is 2 of 2 for (b)(4).
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Event Description
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Concomitant devices: lag screw (part: unknown, lot: unknown, quantity: 1).
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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.
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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It was reported on (b)(6) 2018, during a resident in service, while the sales consultant was putting the helical blade/screw coupling screw into an screw inserter, something was bent.
The devices were not connecting easily.
There was no patient involvement.
This report is 2 of 2 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.
Device history records review was completed for part: 03.
037.
026, lot: 9845838.
Manufacturing location: bettlach, release to warehouse date: apr 18, 2016.
The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.
This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.
Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.
Product investigation was completed.
Visual inspection of the returned device confirmed that connecting screw for blade/screw was bent on the distal end.
No other visual damage was noticed.
Relevant drawings were reviewed during this investigation.
A relevant dimensional inspection was performed.
The distal end of connecting screw had diameter of 5.
33mm and dimensional inspections were completed with calipers ca215p.
This is within the specification of 5.
35 +0/- 0.
03 mm per drawing.
Internal diameter at distal end was 3.
42 mm using gauge pin (gp 32).
This is within specification of 3.
4 +/- 0.
05 mm per drawing.
A definitive root cause could not be determined based on the provided information.
This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.
No new, unique or different patient harms were identified because of this evaluation.
Based on the investigation findings, it has been determined that no corrective and/or preventative 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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