SYNTHES GMBH 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-24MM; SCREW, FIXATION, BONE
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Catalog Number 402.224 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fistula (1862)
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Event Type
Injury
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Manufacturer Narrative
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Additional product code: hrs, ktt.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.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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that patient was being treated for polytrauma, including a fracture of the left humeral paddle with nerve neurolysis ulnar, on (b)(6) 2022.During treatment, surgeon observed the presence of a cutaneous fistula by a previous osteosynthesis of the pallet humerus with oleocranotomy and pin guying to the skin.The surgeon had to remove the osteosynthesis material which had been implanted two years ago.During the operation, a drill bit broke in the patient's bone.The broken piece is not salvageable and was left in place.Procedure was completed successfully with a less than thirty minute delay.This report is for a 2.7mm ti locking scr slf-tpng with t8 stardrive recess-24mm.This is report 8 of 11 for (b)(4) and captures removal of previously implanted devices.The intraoperative breakage of the drill bit is captured under (b)(4).
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Search Alerts/Recalls
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