MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1221

Device Problem Failure to Cut (2587)

Patient Problem No Information (3190)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

The initiator drill was not cutting.

Manufacturer Narrative

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

Manufacturer Narrative

The perforator was not returned for evaluation; therefore, the root cause of this complaint could not be verified.The device history records for this perforator were reviewed.All tests and inspections associated with the assembly and manual functional tests met specification requirements.This complaint in considered to be closed at this time.Should the perforator be returned at a later date this complaint will be reopened and an investigation will be performed.We will continue to monitor for this or similar complaints for this product code and lot number.Device not available.

Manufacturer Narrative

Device was returned for investigation.A follow up will be submitted upon completion of the investigation.

Manufacturer Narrative

Updated udi: (b)(4).Device evaluation: upon completion of the investigation it was noted that the customer¿s complaint of "the initiator drill was not cutting" was not verified.This perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drill hole and there was no erratic and poor cutting action.The device history records for the perforator was reviewed and all test and inspections associated with the assembly process 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4402736
• MDR Text Key: 5364915
• Report Number: 1226348-2015-10019
• 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,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

• 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: BG013S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided; 05/23/2016; 05/23/2016
• Supplement Dates FDA Received: 03/05/2015; 05/03/2016; 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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