MAUDE Adverse Event Report: GREATBATCH SA ACETABULAR REAMER SHAFT; REAMER HANDLE

Model Number 1206-90-10

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

Per email received on 04/16/2014 customer reports; during an unk pt procedure, the tip of the reamer handle broke off due to the torque needed to ream the acetabulum.No pt injury or adverse events reported.Surgical delay was not reported.

Manufacturer Narrative

Complaint sample was evaluated and the reported failure was confirmed.The marred surfaces near the fracture surface indicated misuse.The locking collar retaining pin welds are cracked.Dhr was reviewed and no discrepancies were found.Manual surgical instruments have a limited life-span which is generally determined by wear or damage due to repeated intended use.No further investigation is required.

• Brand Name: ACETABULAR REAMER SHAFT
• Type of Device: REAMER HANDLE
• Manufacturer (Section D): GREATBATCH SA; l' echelette 7; orvin CH-2 534; SZ CH-2534
• Manufacturer (Section G): GREATBATCH MEDICAL SA
• Manufacturer Contact: jennifer meng ; 2300 bershire ln north; minneapolis, MN 55441 ; 7639515359
• MDR Report Key: 4102507
• MDR Text Key: 4758243
• Report Number: 9614497-2014-00206
• Device Sequence Number: 1
• Product Code: EJB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1206-90-10
• Device Catalogue Number: T2756
• Device Lot Number: 56505946
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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