MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD RADIOLUCENT SKULL PINS; RADIOLUCENT PRODUCT ACCESSORIES

Catalog Number A2020

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Linked to mfg report number 3004608878-2020-00521.

Event Description

This is 1 of 2 reports.A customer reported that a a2020 mayfield radiolucent skull pins (sapphire ruby skull pin) fractured.There was no patient injury and no known surgery delay.Additional information has been requested.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The mayfield skull pins were returned for evaluation.Device history record (dhr) - no dhr review was possible as the lot or serial number has not been provided.The investigation showed that two (2) a2020 skull pin were received for evaluation.One of the skull pin was fractured and the other one was not fractured.The fracture in one of the skull pin is likely caused by improper handling ( improper insertion of the skull pin into the skull clamp or improper positioning of the skull clamp).The definite root cause cannot be reliably determined.

• Brand Name: MAYFIELD RADIOLUCENT SKULL PINS
• Type of Device: RADIOLUCENT PRODUCT ACCESSORIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10513464
• MDR Text Key: 206297032
• Report Number: 3004608878-2020-00520
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K071458
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1