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

Catalog Number A3059

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2019

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 a3059 mayfield composite series skull clamp had a knob screw that did not work well in the skull clamp.There was no patient injury nor delay in surgery reported.Additional information was received on 06nov2019 indicating that the threads of the screw knob were stripped and it was hard to turn.The malfunction was discovered during inspection on (b)(6) 2019.

Manufacturer Narrative

Device identifier (b)(4).The device was returned for evaluation.The device history record documentation was reviewed and no anomalies that could be associated with the complaint incident were observed.With respect to the complaint, it was confirmed that 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.The reported complaint is likely caused by wear and tear / improper handling.The definite root cause cannot be reliably determined.

Event Description

N/a.

• 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: 9322143
• MDR Text Key: 189786337
• Report Number: 3004608878-2019-01094
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1