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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A codman perforator did not disengage, piercing patient's dura.There was no reported harm to the patient.

Manufacturer Narrative

Device was returned for evaluation.Upon completion of the investigation a followup will be filed.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the minor abrasion observed on the outside diameter of the outer drill.Thought to be caused by surgeon's utilization in surgery.Test performed on 9/27/2017.Unit completed testing (5 holes) and was found to performed as intended.The dhr was reviewed on 10/03/2017 and it was verified that there were no anomalies during the manufacturing process.Complaint could not be verified.Unit was found to meet all acceptance criteria.We will monitor for this or similar complaints for this product code.No further action is required.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: 6771607
• MDR Text Key: 81960130
• Report Number: 1226348-2017-10549
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791101
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• 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: H74974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2017
• 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
• Patient Age: 42 YR