SYNTHES MONUMENT BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION, APPARATUS, NON-POWERED
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Catalog Number 357.371 |
Device Problem
Sticking (1597)
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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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There was no patient involvement.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record was completed: troutman industries manufactured the buttress / compression nut for 357.399.The certificate of compliance indicates the lot was made to the synthes drawing and manufactured per material requirements and specifications.The lot was inspected and conformed to the synthes incoming final inspection sheet.There were no complaint-related anomalies, material review reports, or non-conformance reports associated with this lot.The parts were released to the warehouse on (b)(4) 2011.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 discovered in sterile processing on (b)(6) 2015 that the aiming arm, buttress compression nut and blade guide sleeve were sticking together when assembled/disassembled.This event did not involve a patient.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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The devices were discovered in a non-working condition on (b)(6) 2015.However, it is unknown when the issue initially/originally occurred.Product investigation summary: the returned aiming arm (part 357.366 / lot 7979724), blade guide sleeve (part 357.369 / lot 6702210), and buttress/compression nut (part 357.371 / lot 6722770) show some wear, but are in working condition with no defects that would impair their function.The devices function as designed.A visual inspection, dimensional inspection, drawing review, and device history record review were performed as part of this investigation.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.The devices were reported to be sticking together upon assembly and disassembly in sterile processing.This complaint is unconfirmed.The complaint condition cannot be replicated.The device assembles and disassembles without sticking or any other difficulty.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.There were no issues found with the returned device; therefore, a corrective action is not warranted.Device 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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