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 Code Available (3191)

Event Date 09/16/2014

Event Type  Injury  

Event Description

Just after perforation during surgery, it was found that blue fragments were scattered in the patient¿s skull.The surgeon requested to investigate whether they were shaved from the plastic sleeve of the perforator.The product was not reprocessed.No surgical delay or adverse consequences to the patient was reported.

Manufacturer Narrative

Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the evaluation of the returned perforator revealed that the blue plastic sleeve is damaged.This was further verified when comparing the returned perforator to a control/new perforator.It appears that the returned perforator was in contact with a hard surface and resulted in the blue plastic material to scrape off the edges of the sleeve.This is the first complaint of this type for this product code.A review of the device history records revealed that this perforator met all testing and inspections associated with the assembly process, as well as meeting specification requirements prior to distribution.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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4111312
• MDR Text Key: 4721328
• Report Number: 1226348-2014-11999
• 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: 09/23/2014
• 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: FG015S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• 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
• Patient Outcome(s): Required Intervention