Product complaint # (b)(4).Patent identifier: (b)(6).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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 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 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 (b)(6) 2021, the patient underwent for an open reduction and internal fixation (orif) procedure.A two-hole va-lcp proximal tibia plate system were used.Upon surgery four (4) va locking screws were inserted to the plate.One (1) locking screw was swapped out due to it didn't lock into the plate.The three (3) va locking screws were left in the plate.There was a one-minute surgical delay.Patient outcome was successful.Concomitant devices reported: va-lcp olecr pl 2.7/3.5 le 2ho l90 sst (part# 02.107.302, lot# unknown, quantity# 1), 2.7mm va lck screw slf-tap (part# 02.211.012, lot# unknown, quantity# 1), 2.7mm va lck screw slf-tap (part# 02.211.014, lot# unknown, quantity# 1), 2.7mm va lck screw slf-tap (part# 02.211.048, lot# unknown, quantity# 1).This complaint involves one (1) device.This report is for (1)2.7mm va lck screw slf-tap.This report is 3 of 5 for (b)(4).
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