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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/19/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

It has been reported that the hoses have holes and some handpieces were defective.The timing of event was stated "before, during, and after".Unknown injuries were reported as a result of the interruption of the leaking hoses.Delay of 45 minutes reported.Patient was under anesthesia.

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: b1, b4, b5, d1, d2, d4, d10, g4, g5, g7, h1, h2, h6 and h10.The customer was asked to return the device; however, the customer provided no means in order to identify the device when the event was reported or during the clinical follow-up performed.As such, it cannot be determined if the product was returned or not or if there was an evaluation and repair performed to the device.No evaluation or repair could be reviewed to determine if the reported issue was confirmed or not.As such, a specific 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.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

It was reported that the hoses have holes and some handpieces were defective.This event occurred before during and after surgery.There was harm to the patient.There was a delay in surgery while the patient was under anesthesia of 45 minutes.No additional consequences have been reported as a result of this malfunction.

• 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: 9323499
• MDR Text Key: 166734912
• Report Number: 0001526350-2019-01010
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other