MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a perforator failed to disengage during cranial surgery for hematoma removal resulting in dural damage and a minor brain contusion.The perforator failed to disengage during the third burr hole at the tentorium.Brain parenchymal surface damage was reported.Hemostasis was performed.Intraoperative visual inspection and postoperative mri were performed, and no major damage was identified.The perforator was used with the medtronic midas rex drill system.There was no hole gap confirmed.No surgical delay was observed.The patient continues in follow-up.No further information was provided.

Manufacturer Narrative

The perforator was not returned for evaluation (as per customer, product not available) therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11325782
• MDR Text Key: 232847798
• Report Number: 3014334038-2021-00025
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J8736G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: MEDTRONIC MIDAS REX DRILL