MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg.Report number: 3004608878-2019-01096.

Event Description

This is 2 of 2 reports.A customer reported that the a3059 mayfield composite series skull clamp rocker arm mount had play in it and hits the teeth when turning the rocker when unlocked; it has a loose rocker arm mount.The problem with the skull clamp was noticed by the operating room (or) technician on (b)(6) 2019 while prepping the room for a surgical case.They noticed play in the rocker arm mounting into the main frame.There was no contact with the patient and no delay in surgery.They replaced it with another skull clamp.

Manufacturer Narrative

Additional information - d10, g4, g7, h2, h3, h4, h6, h10.The device was returned for evaluation.Unit cleaned per protocol.With respect to the complaint, it was confirmed the returned unit did not meet all specific functional test.Unit received with the mayfield 2 lock has up and down movement and the teeth are grinding when rotated.General maintenance and cleaning required.The device history record reviewed with no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr¿s, variances or rework.The reported complaint was confirmed.The complaint is likely caused by wear and tear.The definite root cause cannot be reliably determined.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 9324100
• MDR Text Key: 189715433
• Report Number: 3004608878-2019-01095
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1