(b)(6).Date of device breakage and non-union is not known.Additional device product code: hwc.(b)(4) lot number unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a revision surgery occurred on (b)(6) 2017 due to non-union and plate breakage of a metatarsophalangeal (mtp) joint fusion (mpj).Non-union and device breakage was determined on an unknown date during a postoperative appointment.A broken plate, five (5) 2.7 mm intact variable angle (va) locking screws, and one (1) 2.7 mm intact cortex screws were removed.No surgical delay reported.All broken fragments were removed.No additional medical intervention required.The procedure was completed successfully.Patient was revised with new hardware.The initial procedure for mpj repair occurred (b)(6) 2016.Concomitant devices reported: 2.7 mm va lckng screw (part 02.211.010, lot number unknown, quantity 1), 2.7 mm va lckng screw (part 02.211.012, lot number unknown, quantity 1), 2.7 mm va lckng screw (part 02.211.014, lot number unknown, quantity 1), 2.7 mm va lckng screw (part 02.211.016, lot number unknown, quantity 2), 2.7 mm cortex screw (part 202.878, lot number unknown, quantity 1) this report is for one (1) 2.4/2.7 mm va lcp first mtp fusion plate this is report 1 of 1 for (b)(4).
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