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

Catalog Number 261221

Device Problem Break (1069)

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

A facility reported the perforator (id 261221) malfunctioned and broke.The procedure was completed by removing the perforator from the cranial bone and a 10 minute delay was noted.The perforator was used with an electric midas rex drill.The perforator clicked in place on the drill and the recommended spring tests were performed between each burr hole.It is unknown if the device failure lead to patient injury.

Manufacturer Narrative

The disposable perforator (261221) was returned for evaluation.Device history record (dhr) - the batch record was reviewed for any anomalies or ncs related to the finished lot (5441581), and it is noted that no anomalies occurred during the manufacturing process.Failure analysis: the perforator unit was inspected using the unaided eye.The unit was received disassembled and could not be tested as is.There were visible tool markings on the outer drill noted at the time of the visual inspection."ifu" testing procedure was performed with no observed anomalies (after reassembly).Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all 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.A review of the device history record and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the device history record.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.

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: 12744912
• MDR Text Key: 279825618
• Report Number: 3014334038-2021-00224
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 5441581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• 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