Model Number NL6250 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2019 |
Event Type
malfunction
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Event Description
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A laminectomy is a surgical procedure that removes a portion of the vertebral bone called the lamina.The back muscles are pushed aside rather than cut and the parts of the vertebral adjacent to the lamina are left intact.Per our instruction for use our decker rongeur cup are only intended to be used for cutting/removing tissue.The ifu excludes the use of the instrument at the central nervous system and not used to tear the tissue apart by turning the jaw sideways.Each instrument has to be inspected regarding damage or malfunction due to wear our prior use and must be maintained regularly.If the use of the instrument is as intended, a break off of any parts is very unlikely.Additionally the jaw is secured by two mounted pins which are also ensuring proper function.Only through unintended use by cutting hard tissue, bones, tearing tissue apart by turning the jaw sideways or failed hardening a breakage could occur.Each lot is tested regarding hardening.Specification of hardening: 42-48 hrc.Measurements are recorded on the dhr.There were no failure in the hardening process detected during manufacturing.Therefore failed hardening can be excluded.The complete manufacturing records were checked.There were no deviations or non-conformances during the manufacturing process.No manufacturing, workmanship or material deficiency was identified.Device was not used as intended.
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Manufacturer Narrative
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Correction and additions to the initial report of december 13, 2019.A laminectomy is a surgical procedure that removes a portion of the vertebral bone "called" the lamina.The back muscles are pushed aside rather than cut and the parts of the vertebral adjacent to the lamina are left intact.Per our instruction for use our decker rongeuer cup is only intended for gripping and cutting soft tissue.Due to the dents and the notch on the main mouth part, as well as the widened main mouth part slot, it can be seen that hard material was cut with the instrument.When cutting hard material, the instrument is likely to break.And the ifu excludes the use of the instrument at the central nervous system and not used to tear the tissue apart by turning the jaw sideways.Each instrument has to be inspected regarding damage or malfunction due to wear our prior use and must be maintained regularly.If the use of the instrument is as intended, a break off of any parts is very unlikely.Additionally, the jaw is secured by two mounted pins which are also ensuring proper function.Only through unintended use by cutting hard tissue, bones, tearing tissue apart by turning the jaw sideway or failed hardening a breakage could occur.A hardness test is carried out for each batch and documented in the dhr.Nor errors were found in the hardening process.Weba hardens in-house and it is a validated process.Specification of hardening: 42-48hrc.Therefore failed hardening can be excluded.The complete manufacturing records were checked.There were no deviations or non-conformances during the manufacturing process.No manufacturing, workmanship or material deficiency was identified.Stock was also checked and there was no deviation.It is the first reportable event of this batch.Complaint is assessed as unjustified due to misuse.Device was not used as intended.Bd is given our ifu no.10 for forwarding their user.With the additional not that this forceps is only intended for cutting soft tissue.
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Event Description
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Via email: the pituitary broke while in use.The doctor was removing vertebral disc when it happened.21nov2019 additional information: 1.What was the procedure that was being performed? lamintectomy.2.Did any part the instrument fall into the patient's body, and if so, how was it retrieved? yes.Retrieve by forceps.3.Was there a medical procedure performed to verify if the instrument was in the patient's body, such as an x-ray? no, x-ray was taken.4.What was the patient's outcome? normal.5.Was the procedure completed as planned? yes.6.Can you please send all parts of the instrument for evaluation? missing one portion of the pituitary.
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Search Alerts/Recalls
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