MAUDE Adverse Event Report: GREATBATCH MEDICAL SA OFFSET CUP IMPACTOR

Model Number OR71368569

Device Problems Mechanical Problem (1384); Separation Failure (2547); Device Disinfection Or Sterilization Issue (2909)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2010

Event Type  malfunction  

Event Description

Per email received (b)(6) 2014: customer reports it is not possible to clean and sterilize the r3 positioner properly as the spring mechanism is not detachable.Customer carried out protein test at their facility and protein was detected after cleaning and sterilization.Customer did not indicate there was patient injury or adverse event as a result of the reported incident.

Manufacturer Narrative

Investigation is currently in progress.Once completed a follow-up medwatch 3500a will be submitted.

Manufacturer Narrative

The reported event was not confirmed as the complaint sample was not returned for evaluation.A process review was performed and no discrepancies were found.No further investigation is required.

Manufacturer Narrative

Greatbatch medical is not the legal manufacturer of the device involved in this incident.

• Brand Name: OFFSET CUP IMPACTOR
• Type of Device: OFFSET CUP IMPACTOR
• Manufacturer (Section D): GREATBATCH MEDICAL SA; l' echelette 7; orvin CH-25 34; SZ CH-2534
• Manufacturer (Section G): GREATBATCH MEDICAL SA; l'echelette 7; ch-2534; orvin, ; SZ
• Manufacturer Contact: noe rivera ; 4545 kroemer road; fort wayne, IN 46818 ; 2607557490
• MDR Report Key: 4223657
• MDR Text Key: 5071983
• Report Number: 9614497-2014-00118
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor,distributor,health p
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OR71368569
• Device Catalogue Number: T12083
• Device Lot Number: 09CYW00003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2016
• Was Device Evaluated by Manufacturer?: No
• 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