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

Model Number 261221

Device Problems Break (1069); Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 09/07/2022

Event Type  Injury  

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 a disposable perforator (id (b)(6) did not disengaged, plunged, and broke off.The physician was drilling the 6th hole when the issue occurred.In addition to plunging, a piece of the perforator broke off, leaving the perforator stuck in the patient¿s skull.The perforator was stuck directly above the sagittal sinus and caused minor repairable sinus damage.They had to use a matchstick bit to drill around the perforator to free the perforator.The drill used with the perforator was an electric stryker.The perforator did click in the place in the drill.All the main part of the perforator was recovered.The patient is recovering as expected and there were no further complications attributed to the malfunction.

Manufacturer Narrative

The disposable perforator (id 261221) is not available for return as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Product was not returned for failure analysis, but photos were provided for the investigation.Based off of a visual inspection of the provided photos the perforator clearly broken off, separated.Therefore the complaint condition could be confirmed.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 not received but photos were provided for the investigation.Based off the provided photos the investigation could confirm the complaint.

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: 15495379
• MDR Text Key: 300700880
• Report Number: 3014334038-2022-00218
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 6369861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Date Device Manufactured: 07/13/2022
• 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