Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot, part: 08.501.001.20s, lot: l765033, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 12 march 2018, expiration date: 01 february 2023.A manufacturing record evaluation was performed for the finished article lot 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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Device report from synthes reports an event in united kingdom as follows: it was reported that on (b)(6) 2021, that one (1) of the cables had the needle attached in the wrong direction, this was not user error.It was discovered when attempting to insert the cable into the locking mechanism.While attempting to close the other cable, it tightened fine but when attempting to use the tool to trim the excess it shattered/snapped and left an ineffective closure.All of the initial ties were removed and replaced which caused some minor patient bleeding/ local trauma.There was a twenty (20) minute surgical delay.There were no consequences to the patient.This complaint involves two (2) devices.This report is for one (1) sternal zipfix needle sterile-20pk.This is report 2 of 2 for complaint (b)(4).
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