Intra-operative issue occurred on the (b)(6) 2019.During surgery, a pin got stuck into the secure reverse resection jig code (b)(4), lot #15aa037 and could not be moved to gain desired insertion into the humeral bone.Surgeon completed the surgery using only one pin and the surgery was prolonged of 5 minutes.Event occurred in (b)(6).
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Check oh dhr: by checking the manufacturing chart of the lot #15aa037, no pre-existing anomaly was found on 41 smr -reverse resection jig manufactured.Instrument analysis: the instruments involved in the intra-operative incident (resection jig and pin) were not returned to limacorporate for technical investigation.Pictures were also not available for a visual inspection of instrument condition.Based on the information received, we cannot investigate the root cause of the incident.However, considering that the instrument was 4 years old when the incident occurred and considering the presence of similar complaints on the same instrument code, we can hypothesize that the event was due to a combination of wear due to usage, design factor and surgical factor.After receiving previous similar complaints, in may 2016 the technical drawing of the smr reverse resection jig was adjusted to slightly increase the holes diameter of the jig and therefore further reduce the intra-operative risk of seizure of the pin into the jig holes.Pms data: according to our pms data and considering the resection jigs code 9013.50.304 and 9013.52.304-305 manufactured prior drawing improvement, the occurrence rate of this kind of event is (b)(4).Since the new design has been introduced, only one case has happened with an occurrence rate of (b)(4).Both these occurrence rates are overestimated because they do not consider the reuse of the instrument.Most of these issues happened after several uses of the resection jigs or of the pins.None of these cases caused serious consequences on the patient or prolonged surgical time.Limacorporate will continue to monitor the market to promptly detect the possible recurrence of this issue and assess the effectiveness of the corrective action performed.
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