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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that mayfield ultra base unit (a2101) was difficult to move and transition arm no longer fits.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

Manufacturer Narrative

Mayfield ultra base unit (a2101) was returned for evaluation.The reported complaint was confirmed via inspection of the unit.The base handle had been closed without the 6-inch transitional installed, deforming the hole.The 6-inch transitional teeth were worn, and it needs to be replaced.The shock cushion and ¼ inch pin were worn.The adjustment wrench had worn threads.Unit is beyond integra's 7 years recommended life cycle (manufactured in 2010).General maintenance and cleaning required along with replacement of worn components.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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
• MDR Report Key: 11821716
• MDR Text Key: 250649817
• Report Number: 3004608878-2021-00343
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1