WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS; NAIL,FIXATION,BONE
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Model Number 03.010.435 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.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.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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Event Description
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It was reported that on (b)(6) 2020, the compression device for suprapatellar, extractor, connecting screws and extraction screw were stripped, trocars were bent along with the wire guides, blue handle, black knob broke off, along with buttons on the side to protection sleeve.The surgeon was aggressive and over-torqued products leading to stripping and bending of products.A new set brought into the room.There were 10 minutes of surgical delay.It is unknown if the surgery successfully completed.No patient consequence.This complaint 11 devices.This report is for (1) 12.0mm protection slv straight for 8mm-11mm nails.This report is 6 of 8 for (b)(4).
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