Model Number 1806-3100 |
Device Problem
Failure to Align (2522)
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Patient Problems
Failure of Implant (1924); Unequal Limb Length (4534); Implant Pain (4561)
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Event Date 02/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of the investigation any additional information will be communicated in a supplemental report.
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Event Description
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The customer reported that the patient presented with pain 6 weeks after implantation with a t2 nail.On x-ray it was noted that the screws had not gone through the nail.The surgeon checked the target device prior to the case and also after the case.The customer would like the jig to be inspected.New information and corrections received (b)(6) 2021, according to the adverse incident report: proximal displacement of nail.Patient underwent recon nailing of his right femur on (b)(6) 2021.There were no noticed complications during the procedure.Check x-ray was taken on (b)(6) 2021.No significant problem was identified.Patient reviewed at clinic on (b)(6) 2021.Check x-ray taken showed that there had been proximal displacement of the nail with some collapse and rotation at the fracture site.This was in keeping with the proximal locking screws not being through the nail (allowing proximal migration of the nail).The patient was also sent for an additional true lateral of the hip at that appointment.Patient examined and it was noted that the leg was approximately 2cm short with some slight external rotation of the foot.Patient has subsequently had revision surgery in rvh.
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Manufacturer Narrative
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D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.According to event description ¿the surgeon checked the target device prior to the case and also after the case¿ and no deviation was reported.However, more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.H3 other text : device was not returned.
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Event Description
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The customer reported that the patient presented with pain 6 weeks after implantation with a t2 nail.On x-ray it was noted that the screws had not gone through the nail.The surgeon checked the target device prior to the case and also after the case.The customer would like the jig to be inspected.New information and corrections received 27/05/2021.According to the adverse incident report: proximal displacement of nail.Patient underwent recon nailing of his right femur on (b)(6) 2021.There were no noticed complications during the procedure.Check x-ray was taken on (b)(6) 2021 no significant problem was identified.Patient reviewed at clinic on (b)(6) 2021.Check x-ray taken showed that there had been proximal displacement of the nail with some collapse and rotation at the fracture site.This was in keeping with the proximal locking screws not being through the nail (allowing proximal migration of the nail).The patient was also sent for an additional true lateral of the hip at that appointment.Patient examined and it was noted that the leg was approximately 2cm short with some slight external rotation of the foot.Patient has subsequently had revision surgery in rvh.
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Manufacturer Narrative
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Corrections - please refer to: h6 method, results and conclusion codes d9 / h3 updated as device was returned.B1/b2/h1 corrected.The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the device returned passed the pre-operative function test as intended.The alleged mis-targeting could not be reproduced.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.According to event description ¿the surgeon checked the target device prior to the case and also after the case¿ and no deviation was reported.Although a definitive root cause could not be determined, the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.No corrective actions are required at this time.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
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Event Description
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The customer reported that the patient presented with pain 6 weeks after implantation with a t2 nail.On x-ray it was noted that the screws had not gone through the nail.The surgeon checked the target device prior to the case and also after the case.The customer would like the jig to be inspected.New information and corrections received 27/05/2021 according to the adverse incident report: proximal displacement of nail.Patient underwent recon nailing of his right femur on (b)(6) 2021.There were no noticed complications during the procedure.Check x-ray was taken on (b)(6) 2021 no significant problem was identified.Patient reviewed at clinic on (b)(6) 2021.Check x-ray taken showed that there had been proximal displacement of the nail with some collapse and rotation at the fracture site.This was in keeping with the proximal locking screws not being through the nail (allowing proximal migration of the nail).The patient was also sent for an additional true lateral of the hip at that appointment.Patient examined and it was noted that the leg was approximately 2 cm short with some slight external rotation of the foot.Patient has subsequently had revision surgery in rvh.
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Search Alerts/Recalls
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