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

Catalog Number 26-1221

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the surgeon felt that the rotation (spinning) speed of the perforator became low when trying to drill on the patient's skull on (b)(6) 2017.The surgeon checked the rotation speed, but it did not reach up to 80,000rpm according to the displayed speed on the console.The surgeon replaced to another backup perforator, and the rotation speed reached to 80,000 rpm.There was no surgical delay and no adverse consequences to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Udi: (b)(4).Upon completion of the investigation it was noted that the perforator appears to have been used, visible signs of matter on inner and outer drill components.Drill was functionally tested 10x.Drill performance was acceptable all 10x.Note: the complaint stated the drill did not reach 80,000 rpm.The drill speed is 1,000 rpm nominal (800 rpm min, 1,100 rpm max).The acceptance criteria used on all perforators shipped is 1,000 rpm nominal.It is unclear why a drill would be running at 80,000 rpm.Drill performance was not found defective.No cause can be found for the complaint.This perforator performed per manufacturing specification.No functional issues found in the laboratory.We will continue to monitor for this or similar complaint for this product code and lot number.A review of the dhr did not reveal any anomalies during the manufacturing process.This information has been reviewed by management and determined that no further action is required.Complaint was not confirmed.Based on the results of this investigation no further action is required.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: 6457116
• MDR Text Key: 71837393
• Report Number: 1226348-2017-10235
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 04/04/2017
• 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: KJ077S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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