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

Catalog Number 00880100100

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

(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.Not yet returned.

Event Description

It was reported that during testing, the air dermatome unit was leaking at connection to handpiece.There was no harm in the event.No patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4: (b)(4).The previous repair report for air dermatome, serial number (b)(6), was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated air dermatome, serial number (b)(6).The previous repair was due to a damaged screwdriver and width plate, leaking hose, and calibration error on 16 oct 2018.The previous repair was associated with the current repair which is for a leaking hose, calibration error, and damage to the head and control bar.Thus, the previous repair was a related issue.On 10 jun 2019, it was reported from ochsner lsu health shreveport that an air dermatome was leaking at the connection to the handpiece.Product review of the air dermatome by zimmer biomet surgical on 18 jun 2019 revealed that the calibration was out of specification.The motor speed was within specification but there was an air leak sound.The head and control bar were both damaged.Repair of the air dermatome was performed by zimmer biomet surgical on 18 jun 2019 which included replacement of the hose, head, control bar, motor, motor sleeve, swivel, vespel, semi-circle bearings, bearing spacers, poppet, screws, hinge throttle gasket, hinge throttle, needle bearing, retaining ring, ball bearings, planetary carrier, dowel pin, reciprocating arm, poppet spring, o-rings, poppet housing, eccentric shaft, spring seal, and wave washer.Air dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Service notification number 300174902 dated 10 jun 2019.While the returned product investigation confirmed that the air dermatome was leaking air due to a damaged hose, 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 unit was re-calibrated and the hose, head, control bar, motor, motor sleeve, swivel, vespel, semi-circle bearings, bearing spacers, poppet, screws, hinge throttle gasket, hinge throttle, needle bearing, retaining ring, ball bearings, planetary carrier, dowel pin, reciprocating arm, poppet spring, o-rings, poppet housing, eccentric shaft, spring seal, and wave washer 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

There is 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: 8757795
• MDR Text Key: 151119126
• Report Number: 0001526350-2019-00526
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 63196888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1