Product complaint # (b)(4).Device available for evaluation: complainant part is not expected to be returned for manufacturer review /investigation.Initial reporter occupation: reporter is a j&j sales representative.Device evaluated by mfr: without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, 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 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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It was reported that on an unknown date, on an unknown procedure, the (1) depth gauge for small screws, (2) protection sleeve/ 11/8, (2) drill sleeve / 4.2mm, (2) screwdriver shaft sddrive 165mm, (6) 2.8mm fixed angle drill guide, (3) 7.3mm cannulated screw 32mm thread/140mm, (1) scr rack 6.5 ti&ss cann scrs-16/32 thrds, (1) lckng attach washer tray rfn-advanced, (2) 2.4 va 2-clmn vlr drp 7h hd/3h sft/rt-s, and (2) 2.4 va 2-clmn vlr drp 7h hd/3h sft/lt-s have an unknown allegation.Fixed angle guides don't fit into va locking holes, screws were stripped in process.There was no known hospital or patient involvement.This complaint involves twenty-two (22) devices.This report is for (1) 2.8mm fixed angle drill guide.This report is 8 of 13 for (b)(4).
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