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The event is regarding a 3s hemi small implant originally implanted in 2013 that malfunctioned.The implant was noted by the patient in (b)(6) 2017 to have become visible on the dorsal aspect of the surgical site.As a result, the surgeon reviewed the implant in (b)(6) 2018, noted the implant was in excellent placement, yet removed it in (b)(6) 2018.The surgeon noted there is a hole present on the dorsal aspect of the bone, post removal.There is no information regarding an additional surgery to correct any bone interference at this time.The complaint was confirmed by review of the provided x-ray.As discussed in the surgical technique review section, there are several contributing factors that could have resulted in the reported event; however, none can be definitively determined due to limited details provided.Review of the complaint log revealed one other similar event.Based on the above investigation, no other actions is deemed necessary at this time.If additional details that would impact the conclusion of this report are reported to trilliant surgical, a supplemental report shall be submitted within the defined timeframe.
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Notes to form 3500a and justification for information not provided (in initial or follow-up submission) as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-10 below) as part of internal complaint handling activities.1.Patient date of birth (a2) and weight (a4) not reported.2.Catalog # and serial # (d4) not utilized by trilliant surgical.3.Lot # (d4) could not be confirmed.All possibilities are listed below.4.As a result of item 3 above, expiration date (d4) could not be confirmed.All possibilities are listed below.5.Unique identifier (udi) # (d4) does not apply as these parts were manufactured before this requirement was enacted and are no longer manufactured/distributed.6.Reprocessor name and address (d9) n/a to this report.7.Concomitant medical products and therapy dates (d11) not reported.8.As a result of item 3 above, device manufacture date (h4) could not be confirmed.All possibilities are listed below.9.Section h9 n/a to this report.10.No files attached to this report.Corrected information provided in follow-up submission: b5 - description of event/problem for initial submission - corrected to exclude investigation details.D2 - common device name (product code is correct in initial submission).D3 - email address removed and fax number added.D4 - model #, catalog #, serial #, unique identifier (udi) #.E1 - initial reporter (and associated establishment and telephone number) corrected to physician who reported the event to the distrubutor (sales representative).G3 - additional box checked for health professional.H3 - evaluation summary attached checked, referring to the evaluation discussed in section h10.H10 - corrected data.Additional information provided in follow-up submission: d4 - lot # (see below.) g1 - name (and telephone, email address) updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10 - additional manufacturer narrative.Investigation summary (omitted with original submission): dhr review; while the specific lot number of the involved implant (3s hemi sterile implant - small, 100-00-001) could not be identified, the following lot numbers were identified and reviewed as possibilities: 1.Lot #75db0618 [manufactured 04/19/2012, expiration date 04/30/2014] which had no associated nonconformances (ncrs), reworks (rwks), or deviations.2.Lot #75jb0112 [manufactured 10/09/2012, expiration date 10/31/2014] which had no associated ncrs, rwks, or deviations.3.Lot #75dc0305 [manufactured 04/12/2013, expiration date 04/30/2015] which had no associated ncrs, rwks, or deviations.As a result of the dhr review, it is concluded that there were no identified significant events that correlate to the reported event.Visual inspection: the returned device was visually inspected for any damage or defects.Upon inspection, it was observed that one of the spade barbs seemed to be dull and tool marks apparent on the surface.There were no other observations noted during the visual inspection.Dimensional inspection: the returned 3s hemi sterile implant - small was inspected to the most current revision (rev b) since the lot number cannot be confirmed.All critical dimensions were inspected and are within the established specification of dwg 101-00-001.(note: this specification is for the non-sterile version of this implant.) complaints log review: upon review of the complaint log, there is one (1) other complaint associated with a 3s hemi sterile implant - small: ccr 18-10-003.Simulated use testing: although the part was returned to trilliant surgical, a simulated use testing is not applicable to the realm of this event and cannot be recreated.Surgical technique review: the surgical technique of the implantation was not reviewed due to no details provided as the surgery took place approximately five (5) years ago.However, a review of the provided x-rays upon initial implantation and post removal was completed in efforts to identify the root cause of this event.Due to the limited information provided for this case, there are several contributing factors that could have resulted in the event reported.1.Review of the dorsal x-ray upon initial implantation confirms the placement of the 3s hemi implant, small, non-sterile is appropriate as noted by the surgeon upon removal.2.In review of the lateral view of the provided x-ray, the presence of a hole in the dorsal aspect can also be confirmed.However, it is not definitively determined what contributed to cause the hole to be present.It appears bone resorption could play a contributing factor.3.If a broach was utilized during the implantation surgery, there is a potential that, if the surgeon over-broached the bone, it caused the implant to have additional room to shift post-operatively.4.Potential patient non-compliance.In conclusion, no definitive root cause can be determined based on the information provided.Conclusion: the complaint was confirmed by review of the provided x-ray.As discussed in the surgical technique review section, there are several contributing factors that could have resulted in the reported event; however, none can be definitively determined due to limited details provided.Review of the complaint log revealed one (1) other similar event.Based on the above investigation, no other actions is deemed necessary at this time.If additional details that would impact the conclusion of this report are reported to trilliant surgical, a supplemental report shall be submitted within the defined timeframe per sop qlt-006.
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On 10/05/2018, a trilliant sales representative reported that he was notified of a 3s hemi sterile implant - small (100-00-001) malfunction in a 70-year-old female patient on (b)(6) 2018.The original implantation of this 3s hemi sterile implant - small was in (b)(6) of 2013.The patient noted that a piece of the implant became visible of the dorsal aspect of her surgical site in (b)(6) of 2017.It was not until (b)(6) of 2018 that the patient sought out medical advice from doctor 1.Upon removal, doctor 1 noted that the bone quality was in good condition and that the 3s hemi sterile implant - small was still in "excellent placement".On (b)(6) 2018, the implant was removed and it was noted that the dorsal aspect of the bone had a hole present.Upon doctor 1's assessment of the removal and x-rays, it is unknown if the patient will require an mtp fusion to correct any bone interference.
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