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

Catalog Number A1079

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of service and repair remediation activities associated with capa (b)(4).The device was returned to the manufacturer for service and repair.The unit was cleaned per protocol.It was noted upon inspection that the returned unit did not meet all specific functional tests.The unit was received with a base handle that would not close or hold properly.The adjustment wrench and handle rod were missing.Both shock cushions were identified as worn.New components were added to replace the worn parts.A review of the device's manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances related to the reported failure.

Event Description

The user facility returned the a1079 mayfield radiolucent base unit for service and repair because the unit does not lock.

• Brand Name: MAYFIELD RADIOLUCENT BASE UNIT W/ADAPTORS
• Type of Device: BASE UNITS AND ADAPTERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 9011737
• MDR Text Key: 189991505
• Report Number: 3004608878-2019-00957
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1