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 Brain Injury (2219)

Event Date 03/20/2014

Event Type  Injury  

Event Description

The perforator didn't disengage during surgery.Brain injuries.The incident has been reported to the (b)(6).

Manufacturer Narrative

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

Manufacturer Narrative

The perforator was returned for evaluation and was sent to the supplier.Supplier evaluation revealed that the reported "perforator didn't disengage during surgery" was not verified.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drilled hole.Device history records show all tests and inspections, including a drilling test on each perforator, met specification requirements.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Manufacturer Narrative

The perforator was not returned for evaluation; as such it was not possible to evaluate the subject perforator and determine the root cause of this complaint.The device history records for this perforator were reviewed.All tests and inspections associated with the assembly process, met specification requirements.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Complaint sample not returned.

• 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: 3841430
• MDR Text Key: 4685933
• Report Number: 1226348-2014-11682
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: JD010S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 05/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/07/2014; 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2011
• 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