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

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the transitional arm of the a2101 mayfield ultra base unit does not fit appropriately.There was no known patient injury or surgery delay.

Manufacturer Narrative

Device identifier # (b)(4).The device was returned for evaluation.The device history record (dhr) review was not possible as no lot or serial number was provided during the complaint investigation.Visual inspection and the investigation of the device confirmed the reported condition.The 6in transitional was unable to go into the handle.Unit received with the shock cushion was worn from routine use.6in transitional teeth were worn and needs to be replaced; shock cushion and 1/4in pin are worn.Adjustment wrench has worn threads.The observed condition was likely caused by improperly handling /wear and tear of the device.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: 10358099
• MDR Text Key: 201867738
• Report Number: 3004608878-2020-00432
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• 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: 07/21/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1