MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was a faulty motor as there were very low rpm's.The event timing was during preventive maintenance.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Following sections were updated or corrected : b4, b5, d2, d4, d10, g1, g3, g6, h1, h2, h6, h10, d9.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

The event timing was during biomedical engineering test/check.There is no additional event information available.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the motor ran below specifications and was replaced to resolve the reported issue.It was noted that the device has not been regularly returned for annual pm.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME HANDPIECE, ELECTRICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17226920
• MDR Text Key: 318112608
• Report Number: 0001526350-2023-00602
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375994
• UDI-Public: (01)00889024375994(11)170907(10)63760491
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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: 63760491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 0080200100 ZIMMER DERMATOME 1" WIDTH PLATE; 00880200200 ZIMMER DERMATOME 2" WIDTH PLATE; 00880200300 ZIMMER DERMATOME 3" WIDTH PLATE; 00880200400 ZIMMER DERMATOME 4" WIDTH PLATE; 00880300000 DERMATOME SCREWDRIVER; 00880300110 WIDTHPLATE SCREWS, Z.A.D.
• Patient Sex: Prefer Not To Disclose