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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Brain Injury (2219)

Event Date 04/02/2021

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 that the codman disposable perforator was used on a (b)(6) year-old female and failed to disengage during surgery.Dural damage and a minor brain contusion were observed.During placement of the second burr hole the perforator got stuck in the skull.When the physician pulled it out with a duel only the underdrill remained.The underdrill was pulled out and the physician made 2 burr holes.A surgical delay of greater than 30 minutes was reported.The patient is in follow up.

Manufacturer Narrative

Device history record (dhr)- product 261221, with lot j7406k, was reviewed and there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis- perforator unit was inspected using the unaided eye.Unit was received disassembled and had visible tooling marks and a worn eto label.Instructions for use (ifu) testing procedure was performed with no observed anomalies.The unit was found to perform as intended and fulfilled the acceptance criteria.Root cause analysis- the root cause is undetermined and was unable to be confirmed in the complaint evaluation.A review of the device history record and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the device history record.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.

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: 11853121
• MDR Text Key: 255957623
• Report Number: 3014334038-2021-00100
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR