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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

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 facility reported perforator did not stop when it went through the bone.A medtronic electronic drill was used with the perforator.The patient had a dural bruise however, there was no acute issue from the event.

Event Description

N/a.

Manufacturer Narrative

Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Unit was heavily soiled and showed early signs of rust.The "ifu" testing procedure was performed with some assistance since the inner and outer drill were fused due to interaction with the organic matter present.After drilling a test hole, the inner and outer drill were freed and functioned as intended.The functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• 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: 12351316
• MDR Text Key: 267649710
• Report Number: 3014334038-2021-00174
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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: 5424203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1