WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELIX BLADE 95MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
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Model Number 282.238 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Non-union Bone Fracture (2369); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional product code ktt.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Investigation summary: 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 history: part number: 282.238, lot number: h793959, part manufacture date: 17-dec-2018, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of helix blade 95mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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, a hardware removal was performed due to non-union and revision to total hip replacement.The original date of implant was unknown.The procedure was successfully completed.Concomitant devices reported 135 deg lcp® dhhs(tm) sideplate-std barrel 2 holes (part number 282.61, lot number h757389, quantities 1), screws: cannulated (part number unknown, lot number unknown, quantities 1).This complaint is for one (1) helix blade 95mm.This is report 1 of 3 for (b)(4).
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