MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Catalog Number 00880100100

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problems Abrasion (1689); No Code Available (3191)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the device did not scrape the skin off, rather it just gouged the patient.The event occurred during surgery and there was patient harm, an unknown delay due to getting a new dermatome.No additional unplanned graft was required.No additional event information is available.No additional patient consequences were reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Udi #: (b)(4).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)(4) as documented in the repair reports in livelink.On april 17, 2019, it was reported that the device did not scrape the skin off; rather it just gouged the patient.The customer returned an air dermatome device, serial number (b)(4), for evaluation.The customer also returned a hose and 1"/2"/3"/4" width plates, for evaluation.Product review of the air dermatome on april 25, 2019 revealed that the calibration was within specifications.The motor speed was within specifications but on the low end.The control bar was not in the correct position.The 2 inch, 3 inch, and 4 inch width plates were visibly damaged.Repair of the air dermatome was performed by zimmer biomet surgical on april 25, 2019 which included replacement of the 2 inch width plate, 3 inch width plate, 4 inch width plate, die cast lever, throttle hinge gasket, screws, poppet spring, bearings locking nut, motor, internal retaining ring, spring seal, ball plunger, semi-circle shaft bearings, and vespel bearings.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Notification number (b)(4) dated 4/18/2019.While the returned product investigation confirmed that the control bar was in the incorrect position which could cause the reported issue, 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 device was noted to be functioning as intended after the 2 inch width plate, 3 inch width plate, 4 inch width plate, die cast lever, throttle hinge gasket, screws, poppet spring, bearings locking nut, motor, internal retaining ring, spring seal, ball plunger, semi-circle shaft bearings, and vespel bearings were replaced.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
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8570065
• MDR Text Key: 143722347
• Report Number: 0001526350-2019-00335
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 63415171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 77