Intra operative issue occurred on (b)(6) 2018: a lima pin got stuck inside a hole of the smr reverse resection jig, model# 9013.52.304, lot# 2015aa219.No reported prolonged surgery time nor consequences for the patient.Approximate number of uses of the instrument involved is unknown.Event happened in (b)(6).
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The check of the dhr of the lot # involved (lot #2015aa219) did not show any anomalies on the 24 jigs manufactured with this lot#.No other complaints reported on the same lot#.The involved jig was returned to (b)(4), but the involved pin (model #9066.15.095) wasn't.No pictures of the pin was provided.The returned jig underwent a dimensional check: one (1) of the seven (7) holes of the resection jig resulted to be (very slightly) oval and very slightly under-dimensioned (max deviation -0.022mm), while the diameter of the remaining six (6) holes is compliant to drawing specifications.A functional check was performed with a new pin, which could pass through all the free holes of the returned resection jig, including the oval one.This was expected: in fact, the maximum allowable diameter of the pin (as per drawing) is lower than the measured minimum diameter of the jig hole (in the oval hole).Therefore, the most likely cause for the intra-op issue is that the pin external surface was very damaged (due to previous and possible improper usages of the pin), thus preventing a correct sliding of the pin through the oval hole.No corrective action for this specific case.According to our investigation, the resection jig involved is fully functional with a new (undeformed) pin.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-op risk of seizure of the pin into the jig holes, in case that the external surface of the pin is very damaged.For the similar complaints where we could analyze the affected pieces, the strongly damaged external surface of the pin was found to be the cause of the seizure between pin and jig.In all these cases, no adverse effects for patients were reported.The resection jigs involved in all the similar complaints reported were manufactured before the drawing improvement.(b)(4) 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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Intra operative issue occurred on (b)(6) 2018: a lima pin got stuck inside a hole of the smr reverse resection jig, model# 9013.52.304, lot# 2015aa219.No reported prolonged surgery time nor consequences for the patient.Approximate number of uses of the instrument involved is unknown.Event happened in (b)(6).
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