H2: the complaint sample was returned incomplete to viant for evaluation and the reported event is unconfirmed.The offset cup impactor was returned without the impactor tip but had functioned when threading on and off a cup fixture numerous times under tension without fail as intended.To evaluate the reported failure, the function of the device was checked using a cup fixture per the viant impactor function and resistance test work instruction.The device was able to thread on and off and cup fixture numerous times under tension without any issues or complications.A test impactor tip was utilized as the impactor tip was not returned and the offset cup impactor is intended to be used with it to perform its intended purpose.It is unknown whether or not the impactor tip was used during the surgical procedure.If the device was used without a removable nose (not the intended use), the ratchet mechanism would have to be tightened/ratcheted down to an extreme degree, which is not intended.This would likely lead to additional unintended failures (fractures and/or deformations) and could had possibly led to the ratchet weld failure observed.The ratchet mechanism weld is cracked but not fractured all the way around.Per the above evaluation, the reported event is unconfirmed.Further inspection of the device revealed the following other observations; the threaded tip shows no signs of deformation or damage from threading on and off the cup fixture.The impactor body nose has signs of damage and marks indicating the device may had been used with the impactor tip.The ratchet teeth are worn from repeated use.The pin on the blue knob has translated from its original position and is slightly protruding on the side of the knob.The chain is able to rotate within the impactor body as intended.The universal joints (uj) on the chain shows no signs of breakage or deformation.The device has general wear and tear in the form of scratches/nicks/gouges from repeated use.The ifu sent with this device today, man-004011 rev b, states the following; offset cup impactors are hand-held, re-usable surgical instruments[?].Anticipated useful life offset cup impactor: 600 use cycles, end of life is determined by wear and damage due to intended use, considered at the end of its life and should be discarded, check hinged instruments for smooth movement, when the udi carrier(s) is no longer readable, the instrument is to be discarded, viant devices should only be used by qualified personnel fully trained in the use of the surgical instruments and the relevant surgical procedures, do not modify viant instruments in any way and handle with care at all times.Surface scratches can increase wear and the risk of corrosion, manual surgical instruments have a limited life-span which is determined by wear or damage due to repeated intended use.When a surgical instrument reaches the end of its functional life, clean the instrument of any and all biomaterial/biohazards and safely discard the instrument in accordance with applicable laws and regulations.The viant risk management files were reviewed to the reported failure mode is captured and assessed within the viant device history files (dhf).The review revealed there is a similar failure mode identified and mitigated to the lower possible risk region.It was noted during the trend review, the 4 recent similar reported events had all occurred in the same user facility (3 from the same user).All determined to be unconfirmed.The device history records (dhr) was reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.Assembly of the offset cup impactor with a cup fixture was verified at 100% frequency in operation 140 (assembly), 300 (assembly), & 1 per lot at op 800 (final inspection) during the assembly level.This device has experienced approximately 2.87 years of use.It is unknown exactly how many surgical procedures (cycles) this device has experienced throughout its life in the field.In conclusion, the reported event is unconfirmed since the returned offset cup impactor functioned when threading on and off the cup fixture numerous times without fail as intended.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.D9, g3: device returned to manufacturer for evaluation.H2, h6: updated type of investigation, investigation findings, and investigation conclusions.
|