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OBERDORF SYNTHES PRODUKTIONS GMBH Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL; DRILL, BONE, POWERED
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| Catalog Number 03.505.076 |
| Device Problems
Dull, Blunt (2407); Material Twisted/Bent (2981)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 07/29/2019 |
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Event Type
malfunction
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Manufacturer Narrative
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Additional pro-code: dzj.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 this was a ssro (sagittal split ramus osteotomy) procedure performed on (b)(6) 2019.The surgeon drilled the bone with the drill bit (03.505.076), but the drilling was difficult from the beginning.Then, it was found that the drill bit had rotated eccentrically.S/he used a replacement and completed the procedure.The surgeon commented that connectivity with 03.505.003 shaft might have caused the eccentric rotation.No further information is available.This complaint involves two (2) devices.This report is for one (1) ø1.5 mm drill bit w/8 mm stop 15 mm f/90° scrwdrvr mtrxmandbl.This report is 2 of 2 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.A product investigation was conducted.Visual inspection: the device was found in a good condition.Moreover, there are slightly signs of use visible on the shaft end.The cutting edges and the flutes are intact.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: dimensional features were measured and found to be within specifications per relevant drawings.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Conclusion: our investigation has shown that the received device has only signs of use on surface.This investigation will be rated as unconfirmed, because the reported complaint condition could not be replicated.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications.This lot of (b)(4) pieces was manufactured in march 2017, all devices are distributed and we are not aware of any other complaint for this part- and lot number combination.This and the findings above let us exclude a manufacturing related issue.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 as no product related issue could be detected.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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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 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 this was a ssro (sagittal split ramus osteotomy) procedure performed on (b)(6) 2019.The surgeon drilled the bone with the drill bit (03.505.076), but the drilling was difficult from the beginning.Then, it was found that the drill bit had rotated eccentrically.S/he used a replacement and completed the procedure.The surgeon commented that connectivity with 03.505.003 shaft might have caused the eccentric rotation.No further information is available.Concomitant device reported: shaft (part # 03.505.003, lot # unknown, 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.The device was received, the investigation is in progress, 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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Manufacturer Narrative
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Siemens filed the initial mdr 2517506-2019-00236 on (b)(6) 2019.Additional information (b)(6) 2019): siemens reviewed the instrument data and identified two sample ids: (b)(6).That experienced timeout errors on (b)(6) 2019.Sample id (b)(6) experienced a timeout error during sample lock at 13:02:05, and sample id (b)(6) experienced a tube queued timeout error at 14:09:09.Sample id (b)(6) was queried by the las (laboratory automation system), and routine tests could not begin, because previously tests ordered experienced errors while aspirating the sample.The errors caused the sample (b)(6) to be canceled and rescheduled after the error recovery.The time needed to perform the error recovery and reschedule the tests exceeded the time allowed by the aptio gate wait timeout.Sample id (b)(6) was queried by the las, and routine tests could not begin because previous tests ordered experienced errors while aspirating the sample.Along with the aspiration errors, a flex trash failure halted the analytical module and did not allow the instrument to run tests.The time needed to recover from these errors caused the sample (b)(6) to wait longer than the aptio gate wait timeout.Siemens determined that the samples experienced timeout errors due to multiple sample aspiration errors.The instrument has remained fully functional.There are no reports of a recurrence.Section h6: method, results, and conclusion codes were updated.
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