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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Contusion (1787)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The device attached to the competitor's drill (aesculap) did not disengage properly during craniotomy, and caused brain contusion.

Manufacturer Narrative

Device returned.A follow up will be filed upon completion of the investigation.

Manufacturer Narrative

(b)(4).Device evaluation: upon completion of the investigation it was noted that the customer's complaint was not verified.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved 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.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5844129
• MDR Text Key: 51078131
• Report Number: 1226348-2016-10551
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: DJO185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/04/2016; 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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
• Patient Outcome(s): Required Intervention