MAUDE Adverse Event Report: VIANT MEDICAL, LLC METAL HANDLE OFFSET CUP IMPACTOR

Model Number 255000115

Device Problems Failure to Disconnect (2541); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

It was reported during an unknown patient procedure that the impactor was difficult to removed/unscrew from the implant.No consequences or impact to patient.

Manufacturer Narrative

H10: the complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.The customer provided an image showing the a portion of the metal handle offset cup impactor.The image shows the product identifiers and a bloodied impactor tip.However no conclusion could be drawn based on the image as the full device is not shown and a functional check could not be performed without the device being returned for evaluation.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, · visually inspect for damage and wear.If the instrument is damaged and worn, it is 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 device history records (dhr) were reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.This device has experienced approximately 0.93 years of use.It is unknown how many surgical procedures (cycles) this device has experienced throughout its life in the field.In conclusion, the complaint sample was not received by viant for evaluation and the reported event is non-verifiable.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly and a supplemental medwatch 3500a emdr will be submitted as well.No further investigation is required at this time.G2: complaint information provided by distributor, depuy synthes.Foreign as event occurred in australia.

Manufacturer Narrative

H2: the complaint sample was returned to viant for evaluation and the reported event is unconfirmed.The offset cup impactor had functioned when threading on and off a cup fixture numerous times under tension without fail as intended.The screw coupling was examined and it is apparent the thread was cross-threaded as the crest of the threads has lost it's pointed shape.This material loss was caused by possible misalignment of the screw coupling and adjoining implant cup (not provided by viant).The misalignment then caused the threads to lose its shape.The function of the device was still evaluated and verified using a cup fixture (f-p8269-cup) per the viant impactor function and resistance test work instruction (fwwi-0160).The device was able to thread on and off and cup fixture numerous times under tension without any issues or complications.This was possible considering only the crest of the threads were "trimmed" leaving the remaining thread to function per its intended use.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 ratchet teeth show signs of some wear from repeated use.The ratchet weld has a minor crack it does not impede function of the locking mechanism.The chain is able to rotate within the impactor body but there was slight jamming/friction observed likely from contacting the impactor body.The universal joints (uj) were sprayed with isopropyl alcohol which eliminated some of the jamming/friction initially observed.This did not inhibit the device from functioning which was verified when the function of the device was assessed for the reported event.The universal joints (uj) on the chain shows no signs of breakage or deformation.There is rainbow like discoloration on the surface of the device which is indicative of high heat from sterilization/autoclave.The instructions for use (ifu) sent with this lot (man-000197 rev b) warns "do not exceed 137°c." the impaction plate has impact marks suggesting the device has been used in numerous surgical procedures.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, do not exceed 137°c.Do not use highly alkaline (ph>9) solutions.Repeated processing has minimal effect on these instruments.End of life is determined by wear and damage due to intended use, visually inspect for damage and wear.If the instrument is damaged and worn, it is 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.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 0.93 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 (f-p8269-cup) numerous times without fail as intended.Additionally from the investigation performed, the device has experienced unintended misuse from cross-threading (misalignment) the screw coupling and adjoining implant cup.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: OFFSET CUP IMPACTOR
• Manufacturer (Section D): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer (Section G): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer Contact: tony singh ; 4545 kroemer road; fort wayne, IN 46818
• MDR Report Key: 17775756
• MDR Text Key: 323757499
• Report Number: 3004976965-2023-00017
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255000115
• Device Catalogue Number: 511172
• Device Lot Number: PC5438859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1