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

Catalog Number 26-1221

Device Problems Loss of Power (1475); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that while perforating, the perforator got stuck in the bone.Additional hole were needed to removed the perforator from the bone flap.It was reported that the surgery was delayed, although no specific time of delay was reported.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the visual examination of the returned perforator revealed that there is a segment of bone attached to the perforator.It appears that the perforator got stuck to the skull removing a segment of bone.The exact cause of the reported "the perforator got stuck in the bone" could not be verified.This perforator is excessively dirty (blood and debris found throughout) and there is a fragment of bone attached; therefore, functional testing will not be performed.The label on the perforator has been removed; therefore, the lot number cannot be verified and the device history records cannot be reviewed.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: 5698677
• MDR Text Key: 46562409
• Report Number: 1226348-2016-10404
• 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: 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: 06/03/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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