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

Model Number 255000115

Device Problem Failure to Disconnect (2541)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint sample has not been received for evaluation.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted.Lot number is unknown at this time as it has not been provided.Consequently the manufacturing date is unknown at this time.Complaint information provided by distributor, depuy synthes.Foreign as the event occurred in (b)(6).

Event Description

It was reported during a tha procedure on an unknown patient that after the surgeon drove in the cup, the offset impactor and cup could not be removed.The surgery was completed successfully and there was 20 minute surgical delay.No adverse events nor patient consequence were reported as a result of the malfunction.

Manufacturer Narrative

The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.Surgical instruments are susceptible to wear and tear, and therefore should be checked for defects before use.The applicable device history records (dhrs) were not reviewed as the lot number is unknown.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.D9: device available for evaluation checked no.G3: indicates the date additional information received from customer stating the device will not be returned for evaluation.H6: updated investigation findings and conclusions.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• MDR Report Key: 12217649
• MDR Text Key: 263167290
• Report Number: 3004976965-2021-00004
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1