Model Number MG509R |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported to aesculap inc.That a ankeney sternal retr.Set w/6 bld.35x35mm (part # mg509r) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the crank handle became stuck and was not able to be turned while inside the patient.The handle was forcibly turned using a mallot, which resulted in the creation of metal shavings.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.
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Manufacturer Narrative
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Manufacturer evaluation: the complaint device was returned to the manufacturer for evaluation.A functional evaluation revealed that the handle crank was stuck.The crank handle was replaced and the surface was reworked to resolve the issue.The device history records (dhr) was reviewed for the identified serial number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.An investigation of the returned device confirmed the reported issue of stuck handle crank.The handle crank requires routine maintenance with the application of oil to maintain smoothness.Therefore, the most probable root cause was noted as being improper device maintenance.
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Search Alerts/Recalls
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