OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L380 TAN; ROD, FIXATION, INTRAMEDULLARY
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Catalog Number 472.295S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Blood Loss (2597); No Code Available (3191)
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Event Date 05/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown pfna nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Device evaluated by mfr, manufacture date: 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent revision surgery due to the transverse breakage of an unknown proximal femoral nail antirotation (pfna) nail at the level of the fracture.Initially, the patient had implantation of pfna system for treatment of a subtrochanteric fracture on (b)(6) 2018.During the revision, there was a difficulty in removing the broken fragments.However, all implants were successfully explanted and was replaced with a large locking compression plate (lcp) with 14 holes.There was a surgical delay of two (2) hours and blood loss of about 1350 cc and some complications due to the recovery of nail, longer scar, different approach and reposition fragments.Patient outcome was unknown.(b)(4) will capture the intra-op events, where device caused the surgical delay, blood loss and some complications , while related complaint (b)(4) will capture the post-op events, where an unknown pfna nail had been found to have transverse breakage.Concomitant devices reported: unknown pfna helical blade (part# unknown, lot# unknown, quantity 1) and unknown locking screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) unknown pfna nail.This is report 1 of 1 for complaint (b)(4).
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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.The visual inspection found no product issues that could have contributed to the clinical finding.The investigation of the returned part is documented within (b)(4).No product issues that could have contributed to this clinical finding were found.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 472.295s lot: l391532 manufacturing site: bettlach release to warehouse date: 10.May 2017 expiry date: 01.May 2027 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional data-b5, d1-d4, d10, g2 g5: device is not distributed in the united states, but is similar to device marketed in the usa.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 underwent revision surgery due to the transverse breakage of an unknown proximal femoral nail antirotation (pfna) nail at the level of the fracture.Initially, the patient had implantation of pfna system for treatment of a subtrochanteric fracture on (b)(6) 2018.During the revision, there was a difficulty in removing the broken fragments.However, all implants were successfully explanted and was replaced with a large locking compression plate (lcp) with 14 holes.There was a surgical delay of two (2) hours and blood loss of about 1350 cc and some complications due to the recovery of nail, longer scar, different approach and reposition fragments.Patient outcome was unknown.Concomitant devices reported: pfna helical blade (part#04.027.033s, lot#l829197, quantity#1) pfna end caps (part#04.027.000s, lot# l808773, quantity#1) locking screw (part#04.005.532, lot#l385336, quantity#1) locking screw (part#04.005.530, lot#l391310, quantity#1).
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