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 05/22/2013

Event Type  malfunction  

Event Description

The sales rep reported that (b)(6) said the perforator was not sharp enough to cut through the skull.(requested that replacement be sent to the rep) we recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as a result of those changes we made to our internal mdr reporting procedures.The reporting decision has been changed to malfunction.

Manufacturer Narrative

We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as a result of those changes we made to our internal mdr reporting procedures.The reporting decision has been changed to malfunction.Upon completion of the investigation, it was noted that the supplier performed this evaluation.The drill was visually examined, functional tested and dimensionally inspected.All evaluation tests and inspections had acceptable results.The reported "perforator was not sharp enough to cut through the skull" could not be confirmed.The device history records (dhr) for this perforator were reviewed.All tests and inspections associated with the assembly process, met specification requirements.We will continue to monitor for this or similar incidents 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: 3792911
• MDR Text Key: 21490973
• Report Number: 1226348-2014-11562
• 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: DF005S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2013
• 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