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

Catalog Number 261221

Device Problem Separation Problem (4043)

Patient Problem No Information (3190)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the surgeon used this burr to make a burr hole.It split into two parts , one part came out with drill and other end stuck in bone.Unable to take out.Used a second burr and it happened exactly like the first time.The surgeon then used a different cutting burr and cut the bone into three parts.

Manufacturer Narrative

Udi (b)(4).The complaint sample was not returned to codman, therefore, an evaluation of the device could not be performed.Device history records (dhrs) were reviewed and no anomalies were found.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.

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: 8488898
• MDR Text Key: 145281523
• Report Number: 1226348-2019-00056
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1