MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported by the surgeon that the device needs recalibrated or checked, it is not taking the depth of graft they are being set at.The event occurred at a hospital, during surgery, unknown patient impact.The surgery was completed with another device.No adverse event was reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Product review of the electric dermatome serial number (b)(6) by a zimmer biomet certified service repair technician on (b)(6) 2020 revealed that the unit was slightly out of calibration on the "0" setting.Repair of the device was performed by a zimmer biomet certified service repair technician on (b)(6) 2020 which included replacement of the seal, and bearings.The device, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

No additional event information.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9977276
• MDR Text Key: 188268821
• Report Number: 0001526350-2020-00389
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 2664800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1