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  Injury  

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.

Event Description

An integra sales representative reported on behalf of the customer that the a2020 mayfield radiolucent skull pins fractured during an unspecified procedure.There was patient contact but no patient injury or surgery delay.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Two skull pins were received for evaluation: failure analysis - evaluation of the returned skull pins found one pin was fractured and the other pin appeared to have no damage/defects.Complaint was confirmed via inspection of the returned pins.The results from extensive engineering analysis indicate pin fracture can result from excessive bending and shear load on the skull pin.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• 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: 10543638
• MDR Text Key: 207325546
• Report Number: 3004608878-2020-00528
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1