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

Catalog Number 26-1221

Device Problem Fail-Safe Problem (2936)

Patient Problem Laceration(s) (1946)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not available.

Event Description

(b)(6).During the procedure the safety mechanism necessary to save to dura mater didn't work and the dura was lacerated.The procedure was carried out stopping the bleeding without any consequences for the patient.Repository number: (b)(4).

• 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: 5088797
• MDR Text Key: 26230451
• Report Number: 1226348-2015-10536
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• 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: 08/27/2015
• 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