MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT; BASE UNITS AND ADAPTERS

Catalog Number A2101

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

An integra sales specialist reported on behalf of the customer that the extension arms do not fit into the a2101 mayfield ultra base unit and when they do fit, it is also difficult to pull out.In addition, the lock handle does not go all the way to lock everything in place.There was no known patient contact or surgery delay.

Manufacturer Narrative

Updated fields: d4, d10, g4, g7, h2, h3, h6, h10.Unique device identification (udi): (b)(4).Device history record (dhr) - a dhr review cannot be performed at this time as the serial number provided (b)(6) does not appear to be a valid integra serial number.Device exceeds its expected life of seven (7) years (lot code 114 manufactured in 2011).The reported complaint was confirmed from the evaluation of the returned mayfield base unit.The handle was closed without the 6in transitional being inserted.Further evaluation showed that parts of the devices were worn and needs to be replaced.General maintenance and cleaning required at this time.The observed condition is likely caused by improper handling/ wear and tear.The definite root cause cannot be reliably determined.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: MAYFIELD ULTRA BASE UNIT
• Type of Device: BASE UNITS AND ADAPTERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10671652
• MDR Text Key: 211101441
• Report Number: 3004608878-2020-00602
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2101
• Device Lot Number: 114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1