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

Catalog Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2020

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

A facility reported the perforator did not stop on the second burr hole and continued through the bone and into the dura (plunged).Surgeon felt that added pressure was needed to continue drilling through bone.The procedure was completed with another perforator.No patient injury reported, no medical intervention was required, and the event led to 5 minutes surgical delay.Medtronic drill was used with the perforators.¿this hospital uses a fair amount of these perforators so it may be safe to say user error is not a cause.¿.

Manufacturer Narrative

Updated fields: d4, d10, g4, g7, h2, h3, h4, h6, h10.The perforator was received for evaluation device history record - based on the dhr review conducted, there is no indication that the production process may have contributed to this complaint.Device identifier # (b)(4).Failure analysis - the unit was visually inspected, rust, and/or organic matter was found.Results of instructions for use was performed with no observed anomalies.Results of functional test was found to performed as intended.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

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: 10280922
• MDR Text Key: 202939418
• Report Number: 1226348-2020-00308
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: J7040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR