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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

No further information is currently available.Health canada has been contacted to garner further information regarding the mdi.G2: foreign as the incident was discovered in the health canada mdi database.

Event Description

During the clinical evaluation review of offset cup impactors, an incident was found on the health canada medical device incident (mdi) database for a "standard offset cup impactor" indicating a hazard for "potential for death/injury" that health canada received on (b)(6) 2016 which viant nor the distributor were aware of.It is unknown what the device malfunction, device information, and patient impact are as it is not indicated on mdi # (b)(4).

Manufacturer Narrative

H2: see the below timeline of the evaluation performed for (b)(4) regarding health canada medical device incident (mdi) # (b)(4).16-aug-23: viant became aware of mdi (b)(4) during the clinical evaluation review of offset cup impactors.18-aug-23: viant contacted the importer (stryker orthopedics) for information regarding the incident if available.01-sep-23: importer was unable to locate incident in their system.11-sep-23: viant performs extract of the mdi database, review recalls & safety alerts, and suspects the mdi may be related to a known recall.However, viant is unable to link the recall to the mdi.12-sep-23: viant contacted health canada mdpr for additional information.13-sep-23: health canada mdpr program forwarded the request for additional information to health canada cvp.21-sep-23: viant follow-ups with health canada cvp.Viant notifies importer of current status and requested for information regarding the recall to possibly link the incident.26-sep-23: importer responds to viant they can't be certain this is linked to the recall unless they have a lot number.03-oct-23: health canada cvp responds to viant they cannot fulfill the request of providing a copy of mdi (b)(4).11-oct-23: viant is unable to submit a formal request to health canada ati division as i and viant medical are not a canadian citizen, resident, or currently present in canada.At this time, the following is still unavailable; part number, lot number, malfunction, patient impact, complaint device, and the mdi report.Thus viant is unable to perform a device history record (dhr) review, trend analysis, risk management file review, nor corrections.In conclusion, the reported event is non-verifiable.The root cause is unknown.If viant receives additional information, it will be evaluated, the complaint record will be updated accordingly, and supplemental reports will be submitted accordingly.No further investigation with regard to this complaint is required at this time.Viant will continue to monitor for trends.H6: updated type of investigation, investigation findings, and investigation conclusions based on evaluation.

• Brand Name: STANDARD OFFSET CUP IMPACTOR
• Type of Device: 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: 17730751
• MDR Text Key: 323203439
• Report Number: 3004976965-2023-00016
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other