MAUDE Adverse Event Report: CODMAN* DISP PERFORATOR; DRILLS, BURRS, TREPHINES 7 ACC.

Catalog Number 26-1221

Device Problem Failure to Cut (2587)

Patient Problem No Information (3190)

Event Date 07/08/2012

Event Type  Injury  

Event Description

Affiliate reported that the hospital had difficulty using a total of 14 perforators, which were all reported to the sales rep on a single day.They were blunt and did not cut well.As a result it was estimated that the surgery was delayed for approximately 35 minutes.(b)(4).We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complain (b)(4).A follow-up is bing generated because of the medwatch is being reclassified from malfunction to serious injury.

Manufacturer Narrative

(b)(4): additional information.We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.(b)(4).In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complain (b)(4).A follow-up is bing generated because of the medwatch is being reclassified from malfunction to serious injury.

• Type of Device: DRILLS, BURRS, TREPHINES 7 ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3770944
• MDR Text Key: 4435056
• Report Number: 1226348-2014-11425
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2012
• Date Manufacturer Received: 04/23/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention