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

Catalog Number 26-1221

Device Problems Plunge (1462); Fail-Safe Problem (2936)

Patient Problems Contusion (1787); Laceration(s) (1946)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

(b)(4).During the use, the safety mechanism for dura mater didn't work: the dura mater was lacerated and occurred a cortical contusion with haematic subarachnoid suffusion.At the awakening the patient had hyposthenia and paresthesia at the controlateral hand.These disorders presented for some days during the hospitalization and progressively were solved until the complete dissolution.Repository number: (b)(4).

Manufacturer Narrative

The perforator was not returned for evaluation; therefore, the root cause of this complaint could not be verified.The device history records for the perforator was reviewed and all test and inspections associated with the assembly process (including a 100% functional test to codman), met specification requirements.Should the perforator be returned at a later date this complaint will be reopened and an investigation will be performed.We will continue to monitor for this or similar complaints for this product code.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.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5239572
• MDR Text Key: 31732925
• Report Number: 1226348-2015-10689
• 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: 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: 11/20/2015
• 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: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2015
• 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
• Patient Age: 35 YR