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 Patient Involvement (2645)

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 transition member of the a2101 mayfield ultra base unit was not fitting.A nuero clinician tried multiple transition arms and none worked.There was no patient involvement nor surgery delay.

Event Description

N/a.

Manufacturer Narrative

(b)(4) the device was return for evaluation.The device history record showed no abnormalities related to the reported failure.The investigation of the returned device did confirmed the reported complaint.The returned unit did not meet all specific functional test.The unit was received without the adjustment wrench, the received with the 6" transitional member was not fitting in the lock handle casting, a result of closing the lock handle without a transitional in place which caused the lock handle hole to egg shaped.The observed condition was likely caused by wear and tear/ improperly handling of the device.The definite root cause cannot be reliably determined.

• 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: 10497795
• MDR Text Key: 206107539
• Report Number: 3004608878-2020-00513
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 08/21/2020
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1