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Model Number TKDRIVER |
Device Problems
Accessory Incompatible (1004); Material Twisted/Bent (2981); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that the powered bone biopsy driver allegedly appeared to be "wobbling".The reporting facility did not indicate if the device was used on a patient or if the issue was noted during prep for the procedure.Follow up is being conducted in an effort to obtain additional procedural and patient details.
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Manufacturer Narrative
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H10: the facility contact name was not provided at the time of report.Follow up is being conducted in an effort to obtain the user information as well as additional procedural and patient details.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 04/2028).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: b5, d4 (expiration date: 04/2028), g3.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device not returned.
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Event Description
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It was reported that the powered bone biopsy driver allegedly appeared to be wobbling.It was further reported that the device allegedly bent.There was no reported patient injury.
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Search Alerts/Recalls
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