Model Number 1304.15.230 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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By the check of the device history records, no pre-existing anomaly was detected on the (b)(4) stems that belong to lot number 1814093.This is the first and only complaint received on this lot number.We will submit a final report as soon as the investigation will be completed.
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Event Description
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Intra-operative issue occurred during shoulder surgery: the package of the smr cementless finned stem, product code 1304.15.230, lot 1814093, ster.1800338 was found broken.The issue caused a prolongation of the surgical time of about 5 minutes, the next size of stem was used to complete the surgery.Event occurred in (b)(6).
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Event Description
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Intra-operative issue occurred during shoulder surgery on (b)(6) 2022: the package of the smr cementless finned stem, product code 1304.15.230, lot 1814093, ster.(b)(4) was found broken.The issue caused a prolongation of the surgical time of about 5 minutes, the next size of stem was used to complete the surgery.Patient is male, 72 years old.This event occurred in italy.
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Manufacturer Narrative
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By the check of the device history records, no pre-existing anomaly was detected on the 35 stems that belong to lot number 1814093.According to our records, at least 25 stems with lot number 1814093, ster.(b)(4) have already been implanted and this is the first and only complaint registered on this lot.Following the visual inspection of the retrieved packaging, the type of damages observed makes us believe that they could be related to an incorrect handling of the device and/or as a consequence of a fall or impact: it is very unlikely that these damages may have occurred during standard transport/storage.Stating that: - by the check of the production documents, no pre-existing anomalies were identified - limacorporate is not aware of any other complaint on the same production or sterilization lot numbers - the damages observed suggest they may have been caused by mishandling of the device we conclude that the packaging issue reported is probably related to external factors such as incorrect handling of the item.We would like to specify that the indications provided by the manufacturer, reported on the packaging, on the instruction for use and on the envelopes themselves, clearly specify that the device must not be used if the package is damaged or the vacuum on the envelopes is no longer present: in case of broken packages, the item must not be used on a patient.Based on limacorporate pms data and considering the smr stems with codes 1304.15.Xxx, packaged with the most recent version of the packaging (i.E.Internal pa pouch + 2 vacuumed pouches + boxes with protective sponges, introduced in 2016), we can estimate an occurrence rate of this kind of intra-operative issue of about (b)(4)%.No corrective actions needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.
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Search Alerts/Recalls
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