MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC); ACCESSORIES

Catalog Number A1072

Device Problem Device Slipped (1584)

Patient Problem Injury (2348)

Event Date 06/30/2020

Event Type  Injury  

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 neuro charge nurse reported that the a1072 mayfield disposable adult skull pins (plastic) slipped during a posterior craniotomy procedure on (b)(6) 2020.There was a 15 minute delay in surgery in order to get a new skull clamp and new skull pins.The patient had to be re-pinned and repositioned.No adverse consequence was reported as a result of the delay.

Event Description

N/a.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The evaluation was completed with the provided photo.The observation of the image showed that the tip of the skull pin was slightly damaged.This will affect the intended use of the device.The device history record (dhr) documentation showed no abnormalities related to the reported failure.The reported complaint was not confirmed.The observed condition was likely caused by improper insertion of the skull pin into the skull clamp / improper position of the skull clamp.The definite root cause could not be reliably determined.Integra is closely monitoring this reported condition.

• Brand Name: MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC)
• Type of Device: ACCESSORIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10319225
• MDR Text Key: 200204851
• Report Number: 3004608878-2020-00397
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K923789
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1072
• Device Lot Number: W1911036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1