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 Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

The affiliate reported: dr complained that codman 14mm, perforator takes too long to reach the point of perforating the skull.He mentioned that it is not the first time it happened.Hence for this specific case, initially an opposition, surgical innovation perforator was inserted to the drill by scrub sr but it just didn't work at all.Dr then ask for a codman one which did work but according to him, it is not as fast as he expected.Additional information: dr used the same perforator but complained that it is too slow.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: upon completion of the investigation it was noted that the customer's perforator met functional test acceptance requirements, proper engagement and disengagement was achieved with every drilled hole, there was no erratic or poor cutting.The cutting time (5-6 seconds) for the operator to perforate the board, for each drilled hole, was as expected.The device history records (perforator assembly) show all tests and inspections, including a drilling test, met specification requirements.Based on the 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: 4169609
• MDR Text Key: 5023963
• Report Number: 1226348-2014-12042
• 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: 10/14/2014
• 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: DG004S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2014
• 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