MAUDE Adverse Event Report: ZIMMER SURGICAL ZIMMER SKIN GRAFT MESHER

Catalog Number 00-7701-000-00

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2013

Event Type  malfunction  

Event Description

It was reported that the device was working intermittently.Additional clinical follow up with the customer indicated that the issue occurred in (b)(6) and there was no pt or surgical involvement.

Manufacturer Narrative

The device was returned to the mfr for repair and evaluation.The service record indicates that the device was manufactured on 01/27/1999 and was last repaired on 08/20/2012 for a non-related issue.Evaluation of the device observed that the customer returned a 2195 ratchet, which had an over-exposed set screw inside the gear and prevented the ratchet from fitting to the roller.The right end of the roller was comb.Prior to repair, a test mesh and calibration check could not be performed due to the damaged comb.Customer did not returned any cutters for evaluation.Improper handling by the user most likely caused the damage to the comb, which most likely caused the customer's reported event.Usage of a 2195 ratchet as opposed to the 7701 ratchet most likely caused the damage to the ratchet gear and roller, which likely contributed to the customer's reported event.The device was serviced and returned to the customer.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Type of Device: ZIMMER SKIN GRAFT MESHER
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3823806
• MDR Text Key: 4391068
• Report Number: 1526350-2014-00101
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-7701-000-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1