MAUDE Adverse Event Report: ZIMMERBIOMET SURGICAL MESHGRAFT II COMPLETE

Catalog Number 00-2195-000-00

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2015

Event Type  Injury  

Manufacturer Narrative

The device was manufactured on 01/20/1989 and has no repair history at zimmer surgical since july 2011.Investigation revealed the cutter and roller were dull.It was also noted that the handle and screws were damaged.Prior to repair, the device produced an acceptable test mesh; however, the device was outside calibration specifications.Repair of the device included replacement of the roller, cutter, handle, screws, ratchet spring and sliding pin.The reported event was not reproduced during testing; however, the lack of calibration of the device and the wear to the cutter blades can lead to undesirable mesh.Per the instructions for use, "the meshgraft ii tissue expansion system should be returned every 12 months for inspection and preventive maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy." additionally, per the instructions for use, "the expected longevity of the meshgraft ii tissue expansion system is ten years.Zimmer recommends that units over this age should be replaced because they have exceeded their normal useful life." the device was repaired and returned to the customer.

Event Description

It was initially reported that the device was not working properly.Additional clinical follow up determined that the issue occurred during a surgical procedure that resulted in harm/injury to the patient.It was stated that during the procedure the surgeon harvested two skin grafts that were deemed unusable and had to be discarded.An alternate device was retrieved and used on a third specimen that was able to be used to complete the surgery.There was a delay of an unknown length to the procedure while the patient was under anesthesia.

• Brand Name: MESHGRAFT II COMPLETE
• Type of Device: MESHGRAFT II COMPLETE
• Manufacturer (Section D): ZIMMERBIOMET SURGICAL; 200 west ohio ave; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave; dover, OH 44622 ; 3303438801
• MDR Report Key: 5011809
• MDR Text Key: 23364605
• Report Number: 1526350-2015-00151
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00-2195-000-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/1989
• 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