Model Number 9013.02.303 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This is the first and only complaint received on this lot #.We will send a final mdr once the investigation will be completed.
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Event Description
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During a shoulder primary surgery performed on (b)(6) 2021, the prong on the tip of the smr - inserter-extractor handle (product code 9013.02.303, lot# 14aa199) broke off.No effect was reported on the patient.According to the complaint source, the instrument was used as per surgical technique and the surgery was successfully completed.Event happened in (b)(6).
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Event Description
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During a shoulder primary surgery performed on (b)(6), 2021, the prong on the tip of the smr - inserter-extractor handle (product code (b)(4), lot# 14aa199) broke off while the instrument was being taken apart.The breakage occurred after the instrument was used and outside of the patient.No effect on the patient was reported.According to the complaint source, the instrument was used as per surgical technique and the surgery was successfully completed.No extension of surgical time was reported.Event happened in australia.
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Manufacturer Narrative
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This is the first and only medical complaint received on this lot #.The instrument involved in the complaint is not available to be returned to limacorporate for investigation.According to the complaint source, the instrument was used for a quite number of times (exact number of uses is not known).According to the reported information, the instrument breakage occurred after its use and while it was taken apart from the operation field.No consequences on the patient were reported.Based on the very few information available and taking into account that no further investigation on the instrument is possible (unavailable for being returned to limacorporate), no definitive conclusion can be drawn on the causes of the breakage of the instrument's prong.We can only give evidence that the instrument (reusable and used multiple times during years) had been manufactured in 2014 and the breakage occurred in (b)(6) 2021.Pms data this is the first complaint received on the intra-operative breakage of the inserter-extractor handles.According to limacorporate pms data, the occurrence rate of breakage of the inserter-extractor handles - belonging to the family codes 9013.02.303 is (b)(4).The occurrence rate is overestimated because it does not consider the reuse of the instruments.
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Search Alerts/Recalls
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