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

Catalog Number 26-1221

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

Udi: gtin unavailable, unknown product code.Upon completion of the investigation a follow up report will be filed.

Event Description

I have today received a complaint about our codman perforators at (b)(6).I will send the relevant forms and a dcon collection bag.No additional information is available at this time.

Manufacturer Narrative

(b)(4).The perforator was not returned for evaluation; therefore, the root cause of this complaint could not be verified.We will continue to monitor for this or similar complaints for this product code and lot number.The device history records for this perforator were reviewed.All tests and inspections associated with the assembly and manual functional tests met specification requirements.At this time this complaint is considered to be closed.Should the perforator be returned at a later date this complaint will be re-opened and an investigation will be performed.

Event Description

Per rep: "i have discussed with the trust and unfortunately the patient involved was a high risk of cjd so it was agreed not to save the perforator due to the unacceptably high risk of cross contamination.The reference codes off the box are: ref;26-1221, lot ;dj015s".

• 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: 5764576
• MDR Text Key: 48622553
• Report Number: 1226348-2016-10461
• 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: company representative,foreig
• 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: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: DJ015S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2016
• 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