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

Catalog Number 26-1221

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

The product could not cut well during surgery.The surgeon used the same new product instead and completed the case without problem.There were no adverse consequences to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The reported problem of the product not cutting well during surgery was not verified.The perforator met functional test acceptance requirements with proper engagement and disengagement achieved with every drilled hole.A review of the history device records confirmed that the device conformed to the required specifications prior to distribution.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 considered 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: 4143544
• MDR Text Key: 4772065
• Report Number: 1226348-2014-12030
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: DG017S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 10/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• 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