Model Number METATARSAL REAMER, 18MM |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2023 |
Event Type
malfunction
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Event Description
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On 8/2/2023, it was reported by a sales representative via sems the following: an ar-8944mr-18 metatarsal reamer is getting dull.An ar-8944mr-20 metatarsal reamer is getting dull.An ar-8944mr-22 metatarsal reamer is getting dull.An ar-8944pr-18 phalangeal reamer is getting dull.An ar-8944pr-20 phalangeal reamer is getting dull.An ar-8944pr-22 phalangeal reamer is getting dull.This was discovered during an unspecified procedure, with no adverse event or patient harm.
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Manufacturer Narrative
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Additional information: h6.Complaint is confirmed.Upon visual evaluation, it was noted that the edges of the reamer are worn, showing signs of having been used heavily.Dfu-0023-eo warns against using dull devices.2.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.Dull devices may require replacement if they no longer perform as designed.Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.
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Search Alerts/Recalls
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