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OBERDORF SYNTHES PRODUKTIONS GMBH TI DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
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| Catalog Number 480.95 |
| Device Problem
Device-Device Incompatibility (2919)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing 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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that a dhs lag screw got stuck in the instrument.There were no fragments generated, another implant, was use to complete the procedure, patient status/ outcome / consequences are unknown.This complaint involves two (2) devices.This report is for one (1) ti dhs®/dcs® lag screw 12.7mm thread/95mm.This report is 1 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.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.Part: 480.950, lot: 1l49048, manufacturing site: balsthal, release to warehouse date: october 10, 2018.Visual inspection: the received dhs/dcs-screw is strongly damaged.There are heavy stress marks in a threaded shape on the complete shaft of the screw.The thread flanks are partially flattened and worn.The anodized layer is worn away at all damages which indicates that they were caused post-manufacturing.There are no damages at the octagonal recess visible, the recess is in a untouched condition.Functional test: a functional test cannot be performed as the involved insertion instrument was not returned for evaluation and due to the heavily damaged condition of the shaft.There was no information provided what insertion instrument was used.Due to the untouched condition it can be assumed that the dhs/dcs wrench with octagonal coupling, part 338.302, was not used.Due to the damages at the shaft it can be assumed that the dhs/dcs wrench part 338.060, which is attached to the outside of the shaft was used.Dimensional inspection: checked dimensions with caliper: shaft diameter specification 7.9mm +0.03/-0.02 / measured: 7.89mm = pass distance shaft flats specification 7.15mm 0/-0.08 / measured: 7.14mm = pass octagon distance 1 sw 5.65mm +0.05/+0.01 / measured: 5.66 = pass octagon distance 2 sw 5.65mm +0.05/+0.01 / measured: 5.68 = pass octagon distance 3 sw 5.65mm +0.05/+0.01 / measured: 5.67= pass.Drawing/specification review: drawing was reviewed to verify the relevant dimensions.The drawing is in place since april 2016 and this is the first complaint of this nature for part 480.950, based on that a design related issue can be excluded.Investigation conclusion: the in the complaint description mentioned jamming can not be confirmed without the involved instrument.Nevertheless is the complaint rated as confirmed due to the strong damages all over the device.During the performed evaluation no manufacturing related issue could be detected, all relevant dimensions were within the specification.There was no detailed information about the event provided, for example when the jamming did occur or which instruments was used when it occurred, also was the instrument not returned for evaluation.Next to that is it afterwards not possible to determine which damage at the dhs/dcs screw did occur during the event and which damage during the removal of the jammed instrument.Therefore it is not possible to determine the exact root cause of this event.Based on the strong stress marks at the shaft we can only assume that the wrench 338.060 was to deep inserted onto the shaft and that the flats of the wrench did get stuck at the crossover from the flats to the diameter at the screw shaft.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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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