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

Catalog Number 261221

Device Problem Failure to Auto Stop (2938)

Patient Problem Perforation (2001)

Event Date 02/17/2021

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

2 of 4 reports: different patients, same failure.Other mfg report numbers: 3014334038-2021-00065, 3014334038-2021-00067, 3014334038-2021-00068.A facility reported a perforator failed to disengage and stopped spinning when it reached the inner table of the skull.The perforator contacted the dura.Medtronic was the manufacturer of the electric drill.The perforator clicked into place in the drill.The surgeon had to change to perform a craniotomy and remove a larger bone flap incorporating the perforator site.The patient tolerated the procedure.Three similar incidents happened on 3 different occasions, within a 3-week period.Each patient was treated the same, since it was the same three surgeons working together; the bone flap was expanded with a craniotomy and dura was sutured.

Manufacturer Narrative

Perforator was not returned for evaluation (as per customer, product not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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
• MDR Report Key: 11611318
• MDR Text Key: 243727291
• Report Number: 3014334038-2021-00066
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1