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 Consequences Or Impact To Patient (2199)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Customer complained perforator was dull.After switching to another codman perforator it performed normally.Event occurred during surgery, but did not delay surgery over 30 minutes.Surgeon resolved issue by switching perforators.

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.This complaint is being reported late as the rep forwarded the complaint to an undeliverable email address.It was not until he returned the product without a complaint number to reference in march that codman discovered that the complaint had not been registered as we had not received it.Rep received an email outlining regulatory requirements as well as communication from his manager on the importance of forwarding the complaint to the appropriate location.

Manufacturer Narrative

Upon completion of the investigation it was noted that the visual evaluation of the perforator using high magnification revealed material consistent with biological residue throughout.A portion of the label appears to have been torn off; however, the lot number was clearly visible jg014s.Visual examination of the cutting surfaces did not reveal any anomalies.The cutting surfaces appeared to be sharp and free of burrs, dents or metallurgic defects such as corrosion.The customers perforator met functional test and acceptance requirements; proper engagement and disengagement was archived with every drilled hole, and there was no erratic or poor cutting action.Device history records (perforator assembly) show all tests and inspections, including a drilling test on each perforator, met specification requirements.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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4583088
• MDR Text Key: 5479913
• Report Number: 1226348-2015-10152
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• 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: JG014S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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