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

Model Number 510912

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

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

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was returned to viant for evaluation.Examination of the returned device does not confirm the reported inability to lock the device.Functional examination finds the instrument will lock and remain locked as intended.Other observations: the ratcheting mechanism has been damaged from repeated, heavy use and misuse.There are impaction marks on the blue knob, trigger button, and handle.The ratchet weld is broken and the ratcheting key is heavily worn on all sides including all of the teeth but despite these observations, the device still functioned as intended.It should be noted, the sides of this device and ratcheting mechanism are not intended for impaction and is considered misuse.The device is heavily tarnished, presumably from repeated sterilization.There are multiple scratches, dings, and nicks on all sides of the device.The threaded end has lead thread damage consistent with the device being impacted without a mating device being fully threaded.This remains unknown however.The proximal drive-chain universal joint appears to have been assembled incorrectly.There is damage on the inside of the instrument from unintended articulation with the universal joint.There are deformities identified on the 2 large pins that lock the chain into the body of the instrument.The small pins were inserted into the correct face of the block, however the block face was incorrectly oriented on this complaint sample.It is known this device was released to distribution prior to the corrective action to address this issue.The device history records (dhr) were reviewed and it did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.This device had experienced approximately 4.44 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.In conclusion, the investigation finds the device functions as intended.The device will lock and remain locked as intended.The device shows signs of wear from repeated, heavy use as well as misuse and it appears the proximal joint was assembled incorrectly but no malfunction was observed due to this.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 during an unknown patient procedure that when the doctor went to insert the cup and the blue knob handle would not the lock the rotation on the cup.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: 10518427
• MDR Text Key: 213227264
• Report Number: 3004976965-2019-00052
• 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: 07/19/2019

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: 510912
• Device Catalogue Number: 510912
• Device Lot Number: 2950427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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