Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently undergoing investigation.A device history record review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: sep 11, 2013.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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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Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (aiming arm/lat/f/multiloc proximal humeral nail, part number 03.019.008, lot number 8519199).The subject device was returned with the complaint condition stating: we have received the following instruments for investigation: qty.1 / part 03.010.063 / #lot 8326169 / protection sleeve 12.0/8.0, l 188mm.Qty.1 / part 03.010.063 / #lot 8780671 / protection sleeve 12.0/8.0, l 188mm.Qty.2 / part 03.010.060 / #lot 9798550 / drill bit ø 3.2mm, calibrated, l 340mm.Qty.1 / part 03.019.006 / #lot 8320039 / insertion handle f/multiloc¿ hum.Nailing system.Qty.1 / part 03.019.007 / #lot 8404292 / connecting screw, cannulated.Qty.1 / part 03.019.008 / #lot 8519199 / aiming arm, lateral, f/multiloc¿ prox.Humeral nail.Qty.1 / part 03.010.064 / #lot 1873308 / drill sleeve 8.0/3.2, f/no.03.010.063.Qty.1 / part 03.010.064 / #lot 8811560 / drill sleeve 8.0/3.2, f/no.03.010.063.The multiloc proximal humeral nail ø 8.0mm, right (part 04.016.034s / lot # unknown / quantity 1) was not returned.The articles are in a used condition with slight scratches on the surfaces and guiding holes.The rest of the instruments are in good condition.Investigation: a functional test together with product development (sustaining engineering) was performed.Another nail was available (with the same part number) to reproduce the complained issue.The returned instruments passed the functional test successfully.The drill sleeves and as well the drill bits met the nail holes as intended.No interfering could be detected.Conclusion: unfortunately we are not able to determine the exact cause of this complaint.Based on our investigations, we only can assume that possibly an insufficient connection, or not exactly following the surgical technique, could have contributed to the complained issue.Since the reported occurrence could not be reproduced, we determine this complaint as unconfirmed.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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