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 Date 01/23/2021

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

This is 2 of 2 reports linked to mfg report number 3004608878-2021-00084.A facility reported that the mayfield radiolucent skull pin (a2020) was fractured during a craniotomy procedure.No patient injury or surgical delay was reported.

Event Description

N/a.

Manufacturer Narrative

Device history record: the dhr shows no abnormalities related to the reported failure.Mayfield radiolucent skull pins (a2020) was returned for evaluation.The reported complaint was confirmed from the evaluation.The tip of the skull pin was fractured from the visual evaluation.The dhr review showed that the skull pin was not fractured and met all quality requirement and specification before release.The observed damaged is consistent with improper skull pin placement, improper skull clamp positioning.The associated skull clamp was not returned for evaluation.It is highly recommended that the skull clamp be returned to be tested.This will confirm if the reported complaint was caused by the skull clamp.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 11327484
• MDR Text Key: 234224568
• Report Number: 3004608878-2021-00085
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• 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: W2007057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1