MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FRIWO AC/DC ADAPTER (TYPE A); SEE H10

Catalog Number H301H000202

Device Problems Material Frayed (1262); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).(b)(4).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.Device evaluation results: on 31 july 2019, it was reported that the ac/dc adapter had no visible damage.Per follow up, there was no physical damage, frayed or exposed wires.The plug would not charge unit.While evaluating the device service technician confirmed the reported event and found exposed wires along the cord and bent ac pins.Service technician then scrapped power supply.The power supply was inspected.Probable cause/root cause: if the power supply was damaged/malfunctioned it may not be able to power on or charge the unit.The power supply was scrapped.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation is based on the information that is provided initially and any information that is obtained throughout the follow-up process.Conclusion: this complaint is determined not to be a new confirmed quality or manufacturing issue, no patient impact is noted.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

It was reported that the plug would not charge unit.During the investigation, exposed wires were identified along the cord, and the ac pins were bent.No adverse events were reported as a result of this malfunction.

• Brand Name: FRIWO AC/DC ADAPTER (TYPE A)
• Type of Device: SEE H10
• 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: 9145288
• MDR Text Key: 169150910
• Report Number: 0001526350-2019-00842
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H301H000202
• Device Lot Number: 3214T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• 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