OBERDORF SYNTHES PRODUKTIONS GMBH 15.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC
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Catalog Number 03.404.026S |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problems
Injury (2348); Foreign Body In Patient (2687)
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Event Date 09/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2020, that the patient underwent for a surgery on left proximal femur.During reaming, the ria drill heads and the area of the shaft center of the driver shaft was solved.The four clamping springs of the drill head have all broken off and remains in the patient.It was unknown if the surgery was completed successfully.The patient outcome was unknown.Concomitant device reported: drive shaft for ria (part# 03.404.035, lot# unknown, quantity 1).Synream drill wire (part# 351.706s, lot# 7l10833, quantity 1).This complaint involves one device.This report is for (1) 15.0mm reamer head for ria 2 sterile.This is report 1 of 1 for (b)(4).
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Event Description
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At the initial surgery on (b)(6) the ria system was used for removal only.The donor site was not treated with an implant during the initial surgery.The fracture at the donor site was created on (b)(6) and the surgery was done on (b)(6).The fracture was not treated with synthes implants.Concomitant devices: ria 2 medullary reamer head (part: 03.404.024, lot: 6778009, quantity: 1), ria 2 medullary reamer head (part: 03.404.029, lot: 6773014, quantity: 1), ria 2 medullary reamer head (part: 03.404.028, lot: 6772013, quantity: 1), drive shaft for ria (part: 03.404.035, lot: unknown, quantity 1), synream drill wire (part: 351.706s, lot: 7l10833, quantity 1).
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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.A2: patient date of birth is an unknown date in 1963.H3, h4, h6: part:03.404.026s, synthes lot: 26p3633, supplier lot: n/a, release to warehouse date: november 15, 2019, expiration date: december 01, 2029, supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the reamer head f/ria 2 ø15 was received at us customer quality (cq).All proximal coupling prongs were broken off the reamer head.The received x-rays showed that the prongs remained embedded in the patient.The received condition was consistent with the complaint condition thus the complaint was confirmed.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage document/specification review: current & manufactured revisions were reviewed.Conclusion: the overall complaint was confirmed for the received reamer head f/ria 2 ø15.Although no definitive root-cause can be determined, it is possible the device experienced unintended forces during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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