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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Date 01/24/2014

Event Type  Injury  

Event Description

The affiliate reported: disengagement failure.During the surgery, perforator could not stop and may have caused dura injury to the patient who had subdural hematoma.The event occurred for their third use of the product, which had been sterilized each time before use.There was no surgical delay greater than 30 min.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was stated that the event occurred for their third use of the product, which had been sterilized each time before use.The codman instructions for use under sterility states, ¿the product is for single use only, do not resterilize.¿ use aseptic technique in all phases of handling.Do not reuse.Discard after one procedure.A component of the device is specifically designed to fail if re-sterilized to prohibit reuse, which could cause impairment of the devices function.¿ during the investigation of the device it was found that the outer sleeve is not deformed, it appears a method other than autoclave sterilization was performed.The eto indicator label is missing from the molded sleeve.The drill body and drill driver show some burnishing on their surfaces.The drill body has some additional damage; its cutting edges are nicked and dulled.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 PEFORATOR
• 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: 3635198
• MDR Text Key: 3985135
• Report Number: 1226348-2014-11227
• 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: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention