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 Tissue Damage (2104)

Event Date 11/15/2014

Event Type  Injury  

Event Description

Cod14-28.Affiliate reported that during a craniotomy in the temporal area, the drill didn't stop when requested and so it perforated part of the dura mater.No patient adverse consequences have been reported.The intervention was finished by using a new drill.Repository number: (b)(4) (during use on patient).

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 root cause for the reported problem "the drill didn't stop when requested" was not verified.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drill hole.Device history records show all tests and inspections, including a drilling test on each perforator, met specification requirements.Based on the results of this investigation no further action is requried.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: 4281519
• MDR Text Key: 15998186
• Report Number: 1226348-2014-12125
• 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: 11/26/2014
• 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: JG010S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• 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