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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE PERF L90 TAN; ROD, FIXATION, INTRAMEDULLARY
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| Catalog Number 04.038.390S |
| Device Problems
Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Migration (4003)
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| Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown nail head elem-tfna hel/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.The blade and distal locking screw will remain coded for migration.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) 2018, a patient underwent a second surgery to review a trochanteric fixation nail advance (tfna) nail that presented mobility after insertion in the primary surgery where it was cast on (b)(6) 2018.The surgeon alleges that the mobility of the nail was due to the failures presented by the instruments in the surgery.The instruments they carried brought a damaged piece.Still, the surgeon made the decision to put the nail, as he did not realize that the piece was damaged until later.Therefore, the surgeon decided to put the implant.Subsequently, the implant was moved inside the femur, which could be caused by a poor technique at the time of place.Patient and procedure outcome is unknown.This complaint involves three (3) devices.This report is for (1) unk - nail head elements: tfna helical blade.This report is 1 of 3 for (b)(4).
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Event Description
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This report is for one (1) tfna helical blade perf l90 tan.
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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.Visual inspection performed at customer quality on the returned device observed significant gouging and scratching over the nail locking mechanism mating surfaces.No further issues were noted.The complaint condition is confirmed.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual and raw material criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Conclusion: a definitive root cause for the device damage and reported conditions could not be determined based on the provided information.However, it is possible that any unintended damage to locking mechanism on nail used with the blade, during post-operative activities would have contributed to reported conditions.Also, the extreme gouging and scratching noted on the device could have occurred during removal process.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot, part number: 04.038.390s, lot number: h488767, part manufacturing date: 06 december 2017, manufacturing site: elmira, part expiration date: 01 november 2027, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h488767 of tfna fenestrated helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot h302125 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This 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 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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Device report from mexico reports an event as follows: it was reported that on (b)(6) 2018, a patient underwent removal of a trochanteric fixation nail advance (tfna) nail that presented mobility after insertion in the primary surgery on (b)(6) 2018.In the surgery of (b)(6) 2018 in the step where the yellow guide sleeve is used in the assembling process, the scrub nurse realized that the piece was damaged.When it was time to insert the yellow drill sleeve, the drill didn¿t pass through.The guide couldn¿t be used so the surgeon had to insert a 32cm needle guide without the drill guide.When the doctor tried to insert the helical blade, it was not in the correct position and when wanted to block the blade it did not lock correctly.When removing the nail and the helical blade on (b)(6) 2018, both were damaged.The nail and the helical blade were replaced with new devices.Procedure was successfully completed with unknown surgical delay.Patient outcome is unknown.This report is for an unknown tfna helical blade.This is report 1 of 5 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown tfna helical blade/unknown lot.Part and lot number are unknown; udi number is unknown.Code 3191 also captures the need for device explantation.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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