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  

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

This is 1 of 6 reports linked to other mfg report number: 3014334038-2023-00072, 3014334038-2023-00073, 3014334038-2023-00074, 3014334038-2023-00075, 3014334038-2023-00076.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.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6 & h10.The disposable 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 - visual inspection utilizing unaided eye was performed.Unit 1 was soiled and had a worn label.Unit 2 was lightly soiled with far less wear and tear, likely the replacement unit during surgery.Spring test attempted.Both units had resistance when initially rotating the hudson end, but this was eventually freed through additional rotations of the unit.Once freed, both units passed the spring test as designed.Functional test performed.Both units successfully drilled 5 holes with no issues and functioned as designed.The complaint condition could not be confirmed as the unit passed all functional tests.Root cause- the root cause remains undetermined.Product was received for analysis and the investigation could not confirm the complaint condition.Possible root cause per the failure analyst ¿drill allows to be set incorrectly¿ or ¿user misuse¿.

• 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: 17097975
• MDR Text Key: 316871046
• Report Number: 3014334038-2023-00071
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• 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: 07/28/2023

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: 5727639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• 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