MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME, PNEUMATICALLY-POWERED

Catalog Number 00880100100

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that air dermatome had restricted air flow.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4,b5, d10, g4, g7, h2, h3, h6 and h10.Reported issue: on (b)(6) 2019, it was reported that the unit had restricted air flow.The customer returned an air dermatome device, serial number (b)(6) , for evaluation.The customer also returned a hose and 1/2/3/4 width plates, for evaluation.Dhr review: the device history record (dhr) review was unable to be performed as the dhr associated with this device is not available.This device was manufactured prior to may 2009 where it was identified a robust dhr indexing and handling process was not in place.A corrective and preventative action implemented a serial number logbook to correct this issue.The previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The previous repair report review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(6) four times as documented in the repair reports.The last repair was (b)(6), 2019 where it was reported that the device needed preventative maintenance and the die cast lever, semi-circle shaft bearings, vespel bearings, and ball plunger were replaced.This is not a related issue.Device evaluations results/investigation findings: product review of the air dermatome on (b)(6) 2019 revealed that the calibration was out of specifications at the zero setting only.The motor speed was within specifications but there was a slight air leak in the hose.The 4 inch width plate was damaged.Repair of the air dermatome was performed by (b)(6) on (b)(6) 2019 which included replacement of the 4 inch width plate, swivel, semi-circle shaft bearings, and vespel bearings.Air dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the air hose to leak.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information was received.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8843383
• MDR Text Key: 152711341
• Report Number: 0001526350-2019-00599
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1