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

Catalog Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2021

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 a perforator underwent initial check with midas rex drill prior to use in the patient and the surgical staff reported the perforator ¿felt gritty and not freely moving so they did not want to use it.¿ it was used with a pneumatic drill, it was confirmed the perforator clicked into place in the drill and the recommended spring tests were performed.Another perforator was opened and used without difficulty.

Manufacturer Narrative

The perforator was returned for evaluation.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.The unit was lightly soiled, no anomalies were observed.The returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.Root cause: the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The risk remains acceptable per the risk analysis.

• 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: 11426944
• MDR Text Key: 245127055
• Report Number: 3014334038-2021-00039
• 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: 06/24/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J89A37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1