MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 3 IN 1 SHAVER 5.0MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number N/A

Device Problems Overheating of Device (1437); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Laceration(s) (1946)

Event Date 05/24/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on may 24, 2023 during surgery the relign 3 in 1 shaver 5.0mm caused a burn on the patient.From review of present information surgical intervention required as a suture is at the burn site.No delay was noted.Due diligence is in progress; no addition information has yet been received.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The returned devices were tested for rf functionality to check if there were any issues that would contribute to the reported issue.The devices were found to be conforming to all rf functionality tests.Button functionality on the handpiece was found to be operating within specification.The returned devices were functioning as expected and the reported complaint could not be confirmed.A follow-up discussion with the surgeon involved in the initial complaint revealed uncertainty that the devices in question caused the patient burn.With the evidence obtained through extensive device testing and the additional information provided by the surgeon using the devices, there was no definite evidence that the device, system, or user-misuse caused the burn to the patient.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 cannot be 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.

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.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that on may 24, 2023 during surgery the relign 3 in 1 shaver 5.0mm caused a burn on the patient.The device was hot to the touch per the surgeon.The suture in the photo was not due to the burn but for the surgery.No extra suture was needed, however, additional post op ointment was applied to the burn site.An alternate product was not used to complete the procedure.Due diligence is complete.No additional information is available.No adverse events were reported as a result of this malfunction.

• Brand Name: 3 IN 1 SHAVER 5.0MM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 17171090
• MDR Text Key: 317630172
• Report Number: 0001526350-2023-00611
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00859273007144
• UDI-Public: (01)00859273007144(17)240722(10)F22G22-01
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: R10014
• Device Lot Number: F22G22-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CONTROLLERPN R10001SN (B)(6); FOOTSWITCHPN DWG 7157SN (B)(6); JGRKNT SHT RIGID SZ1PN 110005307LN 0002501768; SHAVER HANDPIECEPN R10023SN (B)(6)
• Patient Outcome(s): Other
• Patient Sex: Female