MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME II HOSE: SYNTHES (AO), 3 M

Catalog Number 00885100203

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Once an investigation of the device is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that during product inspection, air was leaking from the end of the hose.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: b4, d10, g4, g7, h2, h3, h4, h5, h6, h8, h10.The device history record (dhr) for the zimmer air dermatome ii hose: synthes (ao), 3 m, part number 00885100203 and serial number (b)(6) review by de-soutter medical limited noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 02 jan 2020, a returned product investigation was performed on the zimmer air dermatome ii hose: synthes (ao), 3 m.The physical evaluation revealed that the o-ring that seals the airflow from the hose was mis-seated which allowed for air to leak from the hose.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the zimmer air dermatome ii hose: synthes (ao), 3 m had a mis-seated o-ring causing an air leak, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information.

• Brand Name: ZIMMER AIR DERMATOME II HOSE: SYNTHES (AO), 3 M
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9520425
• MDR Text Key: 197312218
• Report Number: 0001526350-2019-01193
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00885100203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1