MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC CODMAN DISP PERFORATOR 11MM; DRILLS, BURRS, TREPHINES & ACC

Catalog Number 26-1222

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

Affiliate reported that during surgery, the product could not cut well.Another product was used to complete the case.There were no adverse consequences to the patient.On 11/17/2014, additional information explained that yes, the customer reported the device was dull.No surgical delay and no adverse consequences to the patient were reported.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was noted that visual evaluation revealed excessive debris throughout the cutting surfaces.The cutting surfaces appeared sharp and free or burs or anomalies.Cutting verification required to further identify root cause of this complaint.Root cause for the reported problem "the product could not cut well" was not verified.The customer¿s [perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every hole, and there was not erratic or poor cutting action.Device history records show all test 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 DISP PERFORATOR 11MM
• 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: 4270068
• MDR Text Key: 15109607
• Report Number: 1226348-2014-12108
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1222
• Device Lot Number: GG002S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• 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