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

Catalog Number A2020

Device Problems Fracture (1260); Material Fragmentation (1261); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A nurse reported that after an unspecified case, it was noticed that some of the mayfield radiolucent skull pins (product id a2020) became dull and one was fractured.The patient had shards of the pin in her head that they were able to retrieve.There was no delay in surgery.Additional information has been requested.

Manufacturer Narrative

Complaint sample was not returned for evaluation; however, a photo provided by the customer was evaluated and the reported condition was confirmed.The device history record (dhr) review showed that the skull pin was not fractured and met all quality requirements and specifications before release.The observed damage was consistent with improper skull pin placement, improper skull clamp positioning.No further investigation required based on the acceptability of risk and no adverse trends identified.

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
• MDR Report Key: 11699356
• MDR Text Key: 260741041
• Report Number: 3004608878-2021-00283
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2020
• Device Lot Number: W1910101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1