Additional device product code: hrx complainant part is not expected to be returned for manufacturer review/investigation.A photo investigation was conducted.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images provided.The images were reviewed, and the complaint condition is confirmed.The shaft rotary seal is damaged at the interface of the shaft and the seal.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Comments: a device history record (dhr) review was conducted: manufacturing location: packaged, sterilized and released by: (b)(4).Release to warehouse date: 01-sep-2021.Expiration date: 31-oct-2021.Part number: 03.404.000s, ria 2 bone harvesting kit 520mm sterile.Lot number: 67p9977 (sterile).Lot quantity: (b)(4).This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the packaging or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404.M001, reaming rod/drive shaft packaged.Lot number: 69p0278.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m012, ria ii ream rod/dr shaft seal.Lot number: 62p4906.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance was reviewed and determined to be conforming.Part number: 03.404m002, graft/irr/suction assembly.Lot number: 67p6275.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m033, ria ii graft filter lot number: 59p5149.Lot quantity: (b)(4).Nr was initiated, incoming inspection, due to one piece having a brown speck of contaminant on the rim.The disposition of the nr was to scrap the one nonconforming piece and release the remainder of the lot from hold.Inspection instruction met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, incoming final inspection, met all inspection acceptance criteria apart from the one piece noted.Certificate of conformance dated 29-may-2020 was reviewed and determined to be conforming.Part number: 03.404m014, irrigation tubing set.Lot number: 67p9624.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance dated 13-aug-2020 was reviewed and determined to be conforming.Part number: 03.404m015, suction tubing set.Lot number: 65p5515.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance dated 21-jul-2020 was reviewed and determined to be conforming.Part number: 03.404m003, manifold assembly packaged.Lot number: 69p0249.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m010, ria ii manifold assembly.Lot number: 67p8140.Lot quantity: (b)(4).Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance dated 14-aug-2020 was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 after dismantling the ria 2, loose articles from the seal were observed.There is no further information available.On (b)(6) 2021, during manufacturer's investigation of the provided image it was identified that the shaft rotary seal is damaged at the interface of the shaft and the seal.This report is for one (1) ria 2 bone harvesting kit 520mm sterile.This is report 1 of 1 for complaint (b)(4).
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