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

Catalog Number 261221

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2023

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 that the outer plastic sleeve on the drill side of a disposable perforator (id 261221) was scraped off during drilling.It was not reported if any particles fell into the surgical site.According to information provided, it is unknown if the drill was electric or pneumatic.It is also unknown if the perforator click in place in the drill, and if the recommended spring tests were performed between each burr hole.It is unknown if the device failure lead to patient injury or surgical delay.

Event Description

N/a.

Manufacturer Narrative

Unique device identification (udi): (b)(4).Or (b)(4).The codman perforator (261221) was returned for evaluation.Failure analysis - the unit was inspected using the unaided eye: it was deformed at the top of the sleeve and the eo label was destroyed.The "ifu" testing procedure was performed with no observed anomalies.The functional testing was performed using the same protocol it underwent at finished goods testing prior to release and the unit was found to perform as intended and fulfilled the 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.However, potential causes of failure include user misuse.The following information was requested: 1.What scraped the sleeve during surgery?>>unknown.2.Did the blue sleeve have excessive contact with the edge of a burr hole?>>unknown.3.Did this happen on the 1st burr hole or a subsequent one?>>unknown 4.Did the unit come in contact with any fixation devices or other equipment during surgery?>>unknown.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17097979
• MDR Text Key: 317832736
• Report Number: 3014334038-2023-00090
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1