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 01/30/2014

Event Type  malfunction  

Event Description

The affiliate reported: it was noted that the product could not cut well during the surgery on (b)(6) 2014.The product was used for the first time and the customer checked the drill in advance.The backup device was used to complete the case.There were no adverse consequences to the patient and no surgical delay reported as for (b)(4), it was reported the device was dull and had difficulty with engagement.The surgeon requests to investigate especially if the tip of the product had any problems with the shape.We have not received farther details.

Manufacturer Narrative

Upon completion of the investigation, a follow up report will eb filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the perforator was evaluated by the supplier and it was found to be within specifications.This perforator met all visual and functional testing requirements.The root cause of the reported problem "did not stop following burr hold completion" was not determined.All evaluation tests and inspections had acceptable results.The perforator met functional test method acceptance requirements; proper engagement was achieved with every drilled hole, and there was no premature disengagement.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 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: 3635100
• MDR Text Key: 19200328
• Report Number: 1226348-2014-11226
• 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

• Date FDA Received: 02/19/2014
• 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: JF024S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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