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

Catalog Number 00880100100

Device Problems Fitting Problem (2183); Failure to Shut Off (2939)

Patient Problem Abrasion (1689)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the hose end wouldn't push onto head of dermatome and hp would not cut off when applied on safety.The event occurred during surgery and the event involved no delay.An additional graft was required to be taken from the patient.An alternate device was used to complete the procedure.No additional consequences were reported.

Event Description

It was reported that the hose end wouldn't push onto head of dermatome and hp would not cut off when applied on safety.The device did not turn off so the person in the room had to unplug the hose and the attached piece would not attach to the hose.The event occurred during surgery and the event involved no delay.An additional graft was required to be taken from the patient.An alternate device was used to complete the procedure.No additional consequences were reported.

Event Description

No additional event information.

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/corrected: b4, b5, d4, d10, g4, g7, h2, h3, h6 and h10.D4: udi# - (b)(4).Reported issue: on (b)(6) 2019, it was reported that the hose end wouldn't push onto head of dermatome and hp would not cut off when applied on safety.The customer returned an air dermatome device, serial number 114009, for evaluation.The customer also returned a hose, for evaluation.Dhr review: the device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated air dermatome serial number(b)(6) as documented in the repair reports in livelink.Device evaluations results/investigation findings: product review of the air dermatome on (b)(6) 2019 revealed that the hose slid onto the swivel with no problem and the throttle lever and poppet worked properly.The torque was low on the thickness lever.The calibration and motor speed were within specification.The customer width plates were not returned for evaluation.Repair of the air dermatome was performed by zimmer biomet surgical on (b)(6) 2019 which included replacement of the 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: the reported event was never confirmed during inspection of the device.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 per for any adverse trends that may warrant further action.

• 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: 8831378
• MDR Text Key: 152343014
• Report Number: 0001526350-2019-00584
• 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,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 64399063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2019
• 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
• Patient Outcome(s): Other