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

Catalog Number 26-1221

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 02/28/2013

Event Type  malfunction  

Event Description

The sales rep reported dr (b)(6) said the perforator was not sharp enough to cut through the skull.No delay in surgery reported as a result of this incident.

Manufacturer Narrative

Upon completion of the investigation, it was noted that as received the drill had dried contamination across all sides of the functional area of the drill.The returned perforator was visually inspected as received, disassembled and cleaned, and then visually and dimensionally inspected.No discrepancies were found.The perforator was reassembled and was functionally tested for cutting and drilling.It was found to meet specification requirements.The reported condition could not be duplicated.Review of the device history record has found no discrepancies.At this time, the complaint is considered to be 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: 3790534
• MDR Text Key: 16059859
• Report Number: 1226348-2014-11546
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

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: ME020S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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