MAUDE Adverse Event Report: UNK PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number UNK PERFORATOR

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code, udi unavailable.Upon completion of the investigation, a follow up report will be filed.

Event Description

It was reported from stryker that it was determined that a perforator bit which fell out of a stryker perforator chuck was likely a codman perforator bit and the perforator remained on the skull.No further information was provided by stryker instrument.Our sales force will collect more detail regarding this event.

Manufacturer Narrative

Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed at this time as 'no complaint sample returned to codman for evaluation'.Trends will be monitored for this or similar complaints.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Device not available.

• Brand Name: UNK PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6446211
• MDR Text Key: 71261051
• Report Number: 1226348-2017-10208
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK PERFORATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention