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 zimmer skin graft mesher was working intermittently.The issue occurred in central sterile processing and there was no patient or surgical involvement.

Manufacturer Narrative

(b)(6) 2012, us and (b)(6) customers were sent an urgent patient safety advisory informing them of the need for proper care and preventive maintenance of their device informing them of improperly maintaining instruments that may cause donor site injuries or result in damage to the graft.The device was returned to the manufacturer for repair and evaluation.The service record indicates that the device was manufactured on 05/10/2013 and has no repair history at zimmer surgical.Evaluation of the device observed prior to repair, the test mesh and calibration check could not be performed due to the damaged comb.The repair of the device included replacement of the comb, side plates and bushing.Customer returned three cutters for evaluation all displayed minor nicks.Only one cutter produced an unacceptable test mesh and was returned to the customer as non-repairable.Customer did not return any carriers for evaluation.Improper handling by the user most likely caused the damage to the comb, which most likely caused the customer's reported event.It is unknown as to which cutter the customer utilized during the reported event; however, one of the cutters did not produce an acceptable test mesh during testing and could have caused 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: 3807322
• MDR Text Key: 17578395
• Report Number: 1526350-2014-00195
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/03/2014

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: 03/03/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 61798
• Patient Sequence Number: 1