MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. POWER SUPPLY, ELEC. DERMATOME

Catalog Number 00882100600

Device Problems Loss of Power (1475); Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Code Available (3191)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(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 would turn on intermittently at first and then would no longer even turn on after a couple of attempts.It was "dragging and was very slow turning" when it did power on slightly.It would not remain on and after two attempts of barely running it did not turn back on again.It was not used on the patient, as this was simply during the testing phase prior to use.It was apparent from the test immediately that it could not be utilized.The patient was under anesthesia when this occurred.The delay was about 30-45 minutes before the surgeon decided to cancel.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.

Event Description

During the investigation, it was discovered that no problem was found with this device.

• Brand Name: POWER SUPPLY, ELEC. DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8955184
• MDR Text Key: 156340183
• Report Number: 0001526350-2019-00736
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100600
• Device Lot Number: 61576478
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other