MAUDE Adverse Event Report: GREATBATCH MEDICAL SA PRECIMED REAMER 48MM

Model Number 1206-90-48

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

Per email received on (b)(4) 2014, customer reports: during an unknown patient procedure, the surgeon stated the reamers are dull.No patient injury was reported."customer does not that there was a surgical delay of 10-15 minutes." no further information was provided.

Manufacturer Narrative

Product has been received by greatbatch and investigation is in process.Once investigation is completed, a follow up medwatch 3500a will be submitted.

• Brand Name: PRECIMED REAMER 48MM
• Type of Device: REAMER
• Manufacturer (Section D): GREATBATCH MEDICAL SA; l' echelette 7; orvin CH-2 534; SZ CH-2534
• Manufacturer (Section G): GREATBATCH MEDICAL SA; l' echelette 7; orvin CH-2 534; SZ CH-2534
• Manufacturer Contact: jennifer meng ; 2300 bershire lane north; minneapolis, MN 55441 ; 7659518359
• MDR Report Key: 3916604
• MDR Text Key: 20859089
• Report Number: 9614497-2014-00030
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1206-90-48
• Device Lot Number: 56469823
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other