(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the complaint device was received and evaluated.Visual observations revealed that the left side of the upper jaw hook was bent inwards.This type of failure could be attributed to blunt force impact; potential root causes include the device hitting bone during a procedure or the device being mishandled.Via functional test, when the trigger was actuated, the jaws did not function properly.The jaws did close successfully, however the jaws couldn¿t open unless by force, pulling on the jaw lever.This complaint is confirmed.A test needle was loaded in the needle tray and the needle lever was actuated.The needle extract and returned successfully.A possible root cause for the jaws not opening as intended cannot be determined.The dhr review indicated that this batch of devices was processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a related complaint search in depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that was released to distribution.And at this time no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).Associated medwatch [mr#: 1221934-2018-52262].
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The previous sales rep for this account left the company and when the current sales rep went to the account, he was handed a box of 8 different devices with no procedure dates, no failures for each device, or any information regarding procedures.The sales rep when observing the devices believes that the following failures are: expressew ii flexible suture passer the jaw is not opening or closing expressew iii without hook the jaw is not opening or closing ratchet handle with jacob's chuck is no longer ratcheting, device is sticking arthro suture scissor the distal tip appears to be bent two cord cutters one is not sliding properly and the other the inside distal tip appears to be broken off anteromedial femoral aimer 7.5mm where the handle and driver meet is loose modular driver 23mm is bent at the distal tip the sales rep stated that the customer did not report any patient harms to him.The devices will be returning for evaluation.
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