Model Number N/A |
Device Problems
Break (1069); Use of Device Problem (1670)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The package insert states "the patient is to be warned by his physician of all surgical risks, including the risk of fracture or breakage.Instruments are available to aid in the accurate implantation of internal fixation devices.Intraoperative fracture or breakage of surgical instruments in general has been reported.Instruments which have experienced extensive use or excessive force are susceptible to fracture.Surgical instruments should only be used for their intended purpose." current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the device evaluation.
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Event Description
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It is reported the lactosorb tap broke during cranial surgery.The broken piece was retrieved and no adverse events were reported.
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Manufacturer Narrative
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This part could potentially be from one of five possible lots, the device history records were reviewed for these potential lots and no non-conformances were identified that would cause or contribute to the event.Visual inspection of the returned instrument confirmed that the tap is broken and does not function as intended.The tip of the tap fractured along the threads.The fractured portion of the tip exhibits deformation along the threads which may be indicative of the attempt to remove the tip from the patients bone by drilling the area around the tap, as stated in the complaint.There are no indications of manufacturing defects.Functional tests could not be performed due to the extent of the damage of the tap.The ifu (instructions for use) warns against using excessive force; "instruments which have experience extensive use or excessive force are susceptible to fracture.Surgical instruments should only be used for their intended purpose." the most likely underlying root cause is that the excessive force was applied while the tap was inserted into the bone.
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Search Alerts/Recalls
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