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

Catalog Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This is 6 of 6 reports linked to other mfg report number: 3014334038-2023-00071 ,3014334038-2023-00072, 3014334038-2023-00073, 3014334038-2023-00074, 3014334038-2023-00075.A facility reported a codman perforator (id 261221) did not stop automatically.The product was in contact with the patient, however, no patient injury reported and the event did not led to surgical delay.The drill used was electric medtronic midas.The perforator clicked in place in the drill, and the recommended spring tests were being performed between each burr hole.The perpendicular approach was maintained through the drill process.There was a constant downward pressure.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The disposable perforator (id 261221) was returned for evaluation.Unique device identification (udi): (b)(4).Failure analysis: visual inspection utilizing unaided eye performed.The unit had a worn label and tooling on the outer drill likely from attempting to free it after plunging during surgery.Spring test attempted: unit had a frozen inner / outer drill but was freed with downward pressure on the inner drill.Once freed, the unit passed the spring test and functioned as designed.Functional test performed: unit successfully drilled 5 holes with no issues and functioned as designed.The complaint condition could not be confirmed, unit passed all functional tests.Root cause- the root cause remains undetermined.The product was received for analysis and the investigation could not confirm the complaint condition.The possible root cause per the failure analyst ¿drill allows to be set incorrectly¿ or ¿user misuse.¿.

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
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17098230
• MDR Text Key: 317828676
• Report Number: 3014334038-2023-00076
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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?: No
• Date Manufacturer Received: 07/25/2023
• 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
• Treatment: ELECTRIC MEDTRONIC MIDAS DRILL
• Patient Sex: Male