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Reporter is jnj representative.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was further reported that the patient was revised to new implant on (b)(6) 2020.Previous implants were removed easily and procedure was successfully completed.Concomitant device reported: tfna helical blade perf l90 tan (part# 04.038.390s, lo# 49p4806, qty 1).Tfna end cap extens.0 tan (part# 04.038.000s, lo# 54p2335, qty 1).Lockscr ø5 l32 f/nails tan (part# 04.005.522, lo# unknown, qty 1).Unknown distal locking screw (part# unknown, lo# unknown, qty 1).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary.Investigation site: cq zuchwil.Selected flow: damage.Visual inspection: the investigation of the returned tfna nail has shown that the nail is through the proximal blade hole broken off.In general the tfna nai in a used condition with slight wear marks at the proximal broken part.Dimensional inspection was performed: the measured dimensions were found to be within the given specifications.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the standard specification of astm f2066 for implants for surgery, ti mo15.The fracture face is homogenous, which indicates material conformity.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the investigation of the returned tfna nail has shown that the nail is through the proximal blade hole broken off.The exact cause of the breakage cannot be defined as there was just few information provided.Based on the information we received we can only assume that there was a complication during the healing process that caused this problem.The tfna nail could not resist the applied force which finally led to the material overload / fatigue failure.Postoperative activities of the patient and a possible instability of the fracture situation (poor bone density / multifragmentary bone fracture) may have played a certain role, too.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot manufacturing location: monument.Manufacturing date: jan 31, 2020.Expiration date: jan 01, 2030.Part number: 04.037.214s, 12mm/125 deg ti cann tfna 235mm/right - sterile.Lot number: 39p0421 (sterile).Lot quantity: (b)(4).One piece was scrapped in cell at op #40, mill slots/relief, for an undersized slot.The remainder of the lot was 100% inspected for this feature and determined to be acceptable.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in-process / inspect dimensional / final ns500294079 met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, tfna assembly inspection ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 17217 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive lot number: 32p2156 lot quantity: 200 production order traveler met all inspection acceptance criteria.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: 17p1887 lot quantity: 1,000 production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from (b)(6) dated 18-oct-2019 were reviewed and determined to be conforming.Part number: 04.037.912.2, lock prong, 125 degree, tfna lot number: 2l87718 lot quantity: 93 purchased finished goods traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 23p3826 lot quantity: 696 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated aug 28, 2019 was reviewed and determined to be conforming.Lot summary report dated oct 24, 2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review dec 18, 2020: dhr reviewed device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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