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

Catalog Number 26-1221

Device Problem Plunge (1462)

Patient Problem Tissue Damage (2104)

Event Date 12/27/2014

Event Type  Injury  

Event Description

Clinician had a perforator on (b)(6) go through the bone and into the brain tissue.Contact at the hospital has the device.On 12/29/2014 affiliate reported: what is the account number? (b)(6).Is there any patient information available(initials, gender, age, date of birth)? none.Was there a delay in surgery greater than 30 minutes? no.How many products were involved with this complaint? 1 26-1221.What is the lot/serial numbers for the product involved? don¿t know.What actions were taken as a result of this incident? repaired the damaged tissue.What is the event date? (b)(6) 2014.What is the date that a (b)(4) representative was first made aware of the event? hospital notified me today 12-29-2014.Surgeon and i spoke during the evening after the case on (b)(6) 2014.In which country did this event occur? usa.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was noted that the customer¿s complaint of "perforator on saturday night go through the bone and into the brain tissue" was not verified.This customer¿s returned perforator met functional test acceptance requirements; proper engagement and disengagement were achieved with every drill hole.The device history records for the perforator was reviewed and all test and inspections associated with the assembly process 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4403198
• MDR Text Key: 5365992
• Report Number: 1226348-2015-10020
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• 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: HG006S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• 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