WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM PLATES; INSTRUMENT,CUTTING,ORTHOPAEDIC
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Model Number 391.98 |
Device Problem
Failure to Cut (2587)
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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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Reporter is a j&j employee.Investigation summary.Visual inspection: the plate cutter for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm platesp (part #: 391.98, lot #: a7pa07) was received at us cq.Upon visual inspection, it was observed that the cutting edge is deformed and dull preventing the device from functioning as intended.Additionally, the leaf spring was observed to be slightly deformed and off centered from its position.No other issues were identified.Functional test: a functional test cannot be performed as the device was returned by itself.Can the complaint be replicated with the returned device(s)? unable to perform.But the plate cutter edge was deformed and dull which could have caused the complaint condition.Dimensional inspection: dimensional inspection could not be performed due to post manufacturing damage.Document/specification review: the following drawing(s) were reviewed: plate cutter micro system, no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the complaint was confirmed for the approximator flex-clip (part #: 279712570, lot #: nw132541), as the cutting edge was observed to be dull and deformed.While no definitive root cause could be determined, it is possible the device encountered unintended forces during use.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot, part number: 391.98, lot number: a7pa07 (wo# 903897), manufacturing site: (b)(4), release to warehouse date: feb 22, 2006.A review of the device history records 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 Description
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It was reported that on september 1, 2020, an inventory check occurred and multiple devices including a mesh cutter, right angle bender, plate cutter, 90 degree screwdriver t-handle, handle for 90° screwdriver, shaft for 90° screwdriver, and matrix rib screwdriver blade self-retaining f/90° screwdriver were found with malfunctions.When tested, the devices would not work properly.They would not turn, hold screws, and some were stripped.Some instruments were bent or dull.There was no patient or procedure involvement.This report is for one (1) plate cutter for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm plates.This is report 8 of 8 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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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