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

Model Number 255000115

Device Problems Fracture (1260); Off-Label Use (1494); Naturally Worn (2988)

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

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was returned to viant for evaluation.Examination of the returned device confirms the reported instrument breakage.The distal drive-chain cardan joint has fractured at the pin fork/block interface.The pin was not returned for evaluation.Visually, it can be seen the cardan joint was assembled incorrectly, leading to the fork with the short pins being assembled closest to the blue knob, however the long pin is to be welded to the forks closest to the blue knob.This incorrect assembly likely contributed to this observed failure, however there were many observations of unintended use throughout the complaint sample, some of which would have directly contributed to the observed cardan joint failure.The device is heavily worn from its more than (5) years of use.Other observations: there were several deformities on the blue knob consistent with pliers, suggesting the chain assembly was over-tightened to a mating device with pliers, which is not the intended use of the device.The ratchet weld is cracked and the ratcheting teeth have been worn from both intended and unintended use.The device has been in distribution for more than five (5) years with wear that indicates it has been frequently, and well used.The ratchet teeth showed signs of wear/deformation, some near the bottom and middle of the key as expected due to repeated intended use.However, several of the teeth near the top of the key, even some in the area on the ratchet key that is typically exposed and not locked into the ratchet housing when the oci is used with a removable nose and an implant properly attached, showed some wear as well.For these teeth to see wear and deformation, the oci would either have to be somehow used without the removable nose, which is not intended, or be used with the removable nose and be tightened/ratcheted down to an extreme degree, which is not intended, and would likely lead to other breakages and deformations.Additionally, there are drag marks (or material scuffs) identified on the proximal side on the ratcheting teeth.The drag marks correspond to damage identified in the slot where the ratchet key is inserted into the handle body.The drag mark extends to the top of the key material, beyond the upper most teeth.However this part of the ratchet key would only come into contact with the oci body if it were pressed all the way down into the oci body.The ratchet key is not intended to be forced down to the point that the key and oci body are contacting, therefore it is unknown why these distinct wear marks exist; there were several gouges on the impaction plate as intended, however there were several on the outside diameter (od) of the impaction plate, as well as on the metal handle, which are not consistent with intended use.There were signs of wear consistent with intended use in the form of scratches, nicks and gouges observed throughout the complaint sample; the returned complaint sample was etched per applicable drawings.The device history records (dhr) were reviewed and no discrepancies were identified.This device had experienced approximately 5.09 years of use.It is unknown as to how many surgical procedures (cycles) this complaint sample had gone through throughout its life in the field.The viant (legacy greatbatch) risk management files were reviewed and the failure mode was identified and mitigated to the lowest possible level.In conclusion, the reported event is confirmed as the distal cardan joint was bent/broken.The bent/broken cardan joint was assembled incorrectly which likely contributed to the observed failure, however there were many observations of unintended use throughout the complaint sample, some of which would have directly contributed to the observed cardan joint failure.However, given the age of the device of five (5) years and (1) month into distribution and the wear identified on all components of the returned handle assembly, the root cause is attributed to device wear and misuse.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.Complaint information provided by distributor, (b)(4).

Event Description

It was reported that the device was broken without additional information.No adverse events nor patient consequence were reported as a result of the malfunction.

• 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: 10518497
• MDR Text Key: 218671880
• Report Number: 3004976965-2020-00008
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 2883765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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