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

Catalog Number 26-1221

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2014

Event Type  malfunction  

Event Description

This complaint is from (b)(6) that was reported through the distributor, (b)(4).Customer reported that: incident occured on (b)(6) 2014, (b)(6).The serial number for the item was (b)(4), last ordered on (b)(4)."the item is a burr that is used in craniotomy cases to drill through the skull to lift the skull bone flap and get access to the brain.When this burr is used it is supposed to stop spinning/drilling once the pressure is off the burr so you don't drill into the brain.The burr did not stop.It was not the equipment/drill that was bad.They checked that and even opened up another burr to finish the case and that burr worked fine.The conclusion was the first burr was bad".One of the operating room nurses was called on (b)(6) 2014, and she informed that the incident did not cause any adverse consequences to the patient, as the surgeon was able to stop the drilling in time.The burr never touched the patient's dura.Burr is available to be returned to codman for evaluation.Please send the evaluation results to customer.

Manufacturer Narrative

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

Manufacturer Narrative

No gtin number available.Upon completion of the investigation it was noted that the root cause of "the burr did not stop" was not verified.A manual operation and disengagement test was performed on the perforator.Thumb pressure on the perforator point produced a smooth, positive spring action and engagement occurred as the hudson was rotated.In the disengagement position; hudson end rotation was smooth.The customer's perforator met functional test acceptance requirements, proper engagement and disengagement was archived with every drill hole.The device history records show all tests and inspections met specification requirements.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC
• Manufacturer (Section D): CODMAN & SHURTLEFF; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3899519
• MDR Text Key: 4650227
• Report Number: 1226348-2014-11775
• 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: Distributor
• 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: 06/27/2014
• 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: HF008S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• 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 Age: 69 YR