MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. MEGMEET AC/DC ADAPTER (TYPE A); N/A

Catalog Number A301A000200

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Device product code - n/a - device is replacement part.The ac/dc adapter (power supply) released into the field from zimmer biomet or from authorized distributor met all functional requirements to be released.A review of receiving inspection report (rir)/dhr of ac/dc adapter (power supply) was unable to be performed as the rir is lot based and the associated serial number (sn) were not noted in the rir¿s.There were no noted ncr¿s or deviations on the rir¿s for the time frame that the ac/dc adapter (power supply) was released to the field.On (b)(6) 2019, it was reported that ac/dc adapter was not working.During evaluation, service technician confirmed the reported event and found exposed wiring near dc connector.The service technician then scrapped ac/dc adapter.The device was tested, inspected as per investigation results and repair.The root cause of why the ac/dc adapter was malfunctioned cannot be determined.If the ac/dc adapter was malfunctioned or damaged it will not provide enough power to the device and will not allow the device to operate as intended.The event was confirmed during inspection and the ac/dc adapter was scrapped.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the megmeet ac/dc adapter was broken, and the prong was damaged.The event occurred at a medical related facility and the patient was not using the device when the event occurred.On investigation it was discovered that there was exposed wiring near the dc connector.No adverse events were reported as a result of this malfunction.

• Brand Name: MEGMEET AC/DC ADAPTER (TYPE A)
• Type of Device: N/A
• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8696918
• MDR Text Key: 148537303
• Report Number: 0001526350-2019-00482
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A301A000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1