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OBERDORF SYNTHES PRODUKTIONS GMBH AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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| Catalog Number 03.231.004 |
| Device Problem
Device-Device Incompatibility (2919)
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| Patient Problem
No Code Available (3191)
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| Event Date 12/14/2018 |
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Event Type
Injury
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Manufacturer Narrative
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Additional product codes: hwc, hrs.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 europe reports an event in the (b)(6) as follows: it was reported that during a procedure using the variable angle (va) condylar instrument system on (b)(6) 2018, the aiming arm and connecting bolt were assembled, along with the locking bolt and nut pre-operatively to familiarize the scrub nurse with the equipment being used for the procedure.The connecting bolt of the aiming arm, which releases the locking nut and bolt for insertion into the va condylar plate, was loosened and removed from the aiming arm.When the scrub nurse attempted to replace the connecting bolt on the aiming arm, the articulation became cross-threaded, preventing the device from advancing fully.The surgical team attempted to remove the bolt both by hand and by use of a wrench but was not successful.The bolt then failed and sheared off completely while attempting to loosen it with a wrench.The bolt could not be removed, even with the use of pliers from another set.The surgical plan was amended because percutaneous/minimally invasive insertion of the shaft screws was no longer possible.A larger distal incision was made, as was a more proximal incision with a skin bridge left between the two (2) incisions.The patient required a blood infusion as a result.Concomitant devices: wrench (part unknown, lot unknown, quantity 1), nut (part unknown, lot unknown, quantity 1).This report is for one (1) aiming arm.This is report 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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Event Description
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It was further reported that the same device was used pre-operation and during operation, but the device was not defective during pre-operation instrument assembly.A larger incision was required to insert shaft screws along the femur.This was because the aiming arm of the percutaneous device was defective, therefore stab incisions could not be used to insert shaft screws (which is the main purpose of the aiming arm for the percutaneous instrumentation).
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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.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 history records review was completed for part: 03.231.004, lot: l342851.Manufacturing location: haegendorf, release to warehouse date: may 03, 2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.The shipped back aiming arm 03.231.004 is in a used condition.The component 03.120.030 connecting-bolt for aiming arm is broken at the shaft.For additional visual inspections the article was cut to inspect the interior life of the instrument.It was found that the thread of the component 03.120.030 connecting bolt for aiming arm and the counter part, the mounting sleeve 60023187 shows very strong damage marks and deforming.Since the component 03.120.030 connecting bolt for aiming arm is broken, the hardness and dimensions at the cross section close to the breakage has been measured.According the drawing ¿stainless steel and cobalt-base alloy heat treating¿ the hardness of the bolt and the component 60023187 ¿mounting sleeve¿ has following specifications: shall: min.48 hrc.Result for 03.120.030 connecting bolt for aiming arm the actual value is: 48.6 hrc.Result for 60023187 ¿mounting sleeve¿ the actual value is: 48.6 hrc.The result of the dimensions inspection, close to breakage is in tolerance as defined on drawing.Therefore, no manufacturing failure has been found.The breakage off the bolt was caused because of misalignment and extreme force impact by assembling of 03.120.030 connecting bolt for aiming arm and the mounting sleeve 60023187.No manufacturing related issue was identified and/or confirmed.Based on the provided information we assume that the in the complaint description mentioned cross-threading is the cause of the complained malfunction.It is visible that the first thread flanks of the connection bolt did get damaged by this cross-threading.This damage did lead to a damage of the counter thread in the mounting sleeve.With each further turn of the bolt the damages did get worse till the device was completely blocked in the mounting sleeve and finally the connection bolt broke due to a mechanical overload.The deformed shaft, the visible strong tool marks at the hexagon and the the fracture face with the typical view of a forced rupture are clear indications for the overload.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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