SYNTHES GMBH 3.5MM TI LCP LOW BEND MEDIAL DSTL TIBIA PL/8H/RIGHT/161MM; PLATE, FIXATION, BONE
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Catalog Number 04.112.518S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for fracture of distal tibia.In the surgery, the surgeon tried to fix the plate with a screw, but the screw idled at the screw hole located distal to the plate.Another screw of the same size was used to the same hole, but the screw idled again and did not lock.The surgeon gave up locking the hole of the plate with a screw and completed the procedures.The surgery was completed with no surgical delay.No further information is available.This report is for one (1) 3.5mm ti lcp low bend medial dstl tibia pl/8h/right/161mm this is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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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Search Alerts/Recalls
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