MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES, & ACC.

Catalog Number 26-1221

Device Problem Plunge (1462)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Affiliate reported that there is an area where the perforator tore the dura.Under normal circumstances, this is dangerous, in this patent, it is possibly catastrophic as the area where the perforator hole is over the speech and motor area.

Manufacturer Narrative

Gtin: unknown as product code was not provided.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the affiliate was contacted regarding product return and advised "i have not been able to locate the perforator in order to send it back.I have contacted the customer and they don¿t have it anymore as it was discarded".As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore; the lot number was not reported; therefore, it is not possible to review the device history records.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES, & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4568229
• MDR Text Key: 5551813
• Report Number: 1226348-2015-10142
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• 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