MAUDE Adverse Event Report: GREATBATCH MEDICAL SA ACETABULAR REAMER 50MM CROSS

Model Number T172

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958); Device Handling Problem (3265)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 03/12/2012

Event Type  Injury  

Event Description

Per email received (b)(4) 2012 customer reports the acetabular reamers did not mill.The teeth were totally worn and the surgeon had to apply too much force.The reamer went through the bone and there was a cement leak possibly going to the peritoneum.Customer reports pt injury and that an unanticipated surgical complication occurred.No additional info was provided.

Manufacturer Narrative

Review of the returned parts confirms that the teeth are worn and, in some cases, damaged from years of use.Use of the devices in this state is advised against in the instructions for use that accompanies the parts, which states that all cutting edges should be inspected for damage and wear prior to use.The parts should not have been used in this state.No corrective action will be taken.The parts were lifetime worn.

• Brand Name: ACETABULAR REAMER 50MM CROSS
• Type of Device: ACETABULAR REAMER 50MM CROSS
• Manufacturer (Section D): GREATBATCH MEDICAL SA; l' echelette 7; orvin CH-2 534; SZ CH-2534
• Manufacturer (Section G): GREATBATCH MEDICAL SA
• Manufacturer Contact: jennifer meng ; 2300 bershire lane north; minneapolis, MN 55441
• MDR Report Key: 3697721
• MDR Text Key: 4251494
• Report Number: 9614497-2014-00004
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T172
• Device Catalogue Number: 2014-50
• Device Lot Number: 2292950001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2012
• Was Device Evaluated by Manufacturer?: Yes
• 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