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 Code Available (3191)

Event Date 08/27/2013

Event Type  malfunction  

Event Description

The customer reported that the surgeon complained that the codman disposable perforator was not sharp enough.No adverse consequences to the patient and/or delay in surgery greater than 30 minutes were verified.The customer would like a warranty replacement.

Manufacturer Narrative

Per the new matrix on (b)(4) 2013, this file is being reported as a malfunction.Upon completion of the investigation, it was noted that the supplier evaluation revealed that the drill body has damaged tangs; at the distal end of each tang, the outer diameter is burnished and scored (shallow cuts into the surface), and the cutting edges are dulled, (deformed, rounded).Excluding the damaged areas, their cutting edges were judged to be sharp.The perforator's poor cutting action is related to the damage on the drill body and inner drill.The device history records for this perforator were reviewed, and it shows that all tests and inspection, including a drilling test on each perforator met specification requirements.We will continue to monitor for this or similar complaints for this product code.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: 3551794
• MDR Text Key: 4102473
• Report Number: 1226348-2014-10162
• 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: User Facility
• Reporter Occupation: Other
• 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: FF001S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2013
• Initial Date FDA Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2013
• 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