WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER; ROD, FIXATION, INTRAMEDULLARY
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Model Number 04.016.038S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported that on (b)(6) 2019, the patient had hardware removal of one (1) multiloc humeral nail, one (1) multiloc screw length 50mm, one (1) multiloc screw length 42mm, one (1) multiloc screw length 48mm, one (1) multiloc screw length 40mm, one (1) titanium locking screw length 34mm, and one (1) titanium locking screw length 36mm due to shoulder pain and limited mobility of humerus.There were four part proximal humerus fracture fixed with the nail but the bone had gone on to die.The surgeon removed all the implants because the head just fell into various collapse and take the dead bony fragments.Initial surgery was done on (b)(6) 2018.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This report is for one (1) 9.5mm ti multiloc proximal humeral nail.This is report 1 of 7 for complaint (b)(4).
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Event Description
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(b)(6) 2019: updated event description: it was reported that on (b)(6) 2019, the patient had hardware removal due to non union, one (1) multiloc humeral nail, one (1) multiloc screw length 50mm, one (1) multiloc screw length 42mm, one (1) multiloc screw length 48mm, one (1) multiloc screw length 40mm, one (1) titanium locking screw length 34mm, and one (1) titanium locking screw length 36mm due to shoulder pain and limited mobility of humerus.There were four part proximal humerus fracture fixed with the nail but the bone had gone on to die.The surgeon remove all the implants easily because the head just fell into various collapse and take the dead bony fragments.Initial surgery was on (b)(6) 2018.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This complaint involves seven (7) devices.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history lot.Part: 04.016.038s.Lot: 9221170.Manufacturing site: mezzovico.Release to warehouse date: 17.Dec.2014.Expiry date: 01.Dec.2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Lot number provided for reporting.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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