MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ACTIVECARE +SFT SYSTEM WARNING:; SLEEVE, LIMB, COMPRESSIBLE

Catalog Number A502B000101

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Device product code- jow.The device history record (dhr) of activecare+sft unit serial number (b)(4) was reviewed and noted no related non-conformance, requests for deviation (rfd) or any other issues with the repair.The dhr review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Upon reviewing mcs legacy complaints data and dhr it was noted that with current serial number (b)(4) the device was not repaired previously.Upon reviewing dhr, when the device serial number was (b)(4) the device was repaired 1 time for device not turning on issue and it is related to current reported event.Note: on 28 february 2017, the device serial number was updated (b)(4).Again in 2015 the device serial number was updated (b)(4).Hence for trace-ability of repairs purpose the repair work done on (b)(4) is considered as previous repair.On 01 may 2019, it was notified that device would not turn on because the battery does not charge.While evaluating the device service technician confirmed the reported event and found the below mentioned errors.Ac/dc adapter right ac pin was broken and the wiring was exposed near dc connector.Both extension tubes have broken connectors.Carrying strap was missing.Battery had reached to end of life (eol) stage.The service technician then arranged, replaced with the below mentioned components for the device and confirmed that the device was functioning as intended.The device was tested, inspected, repaired.Carrying strap (a504a155010), battery pack (503a210004), power supply us type (301e001900), extension tubes (a501a120101).The root cause of the reported event was due to end of life (eol) of battery.If the battery had low capacity/reached to end of life (eol) condition intended it may not be able to power on the unit if it is not plugged into ac power.The event was confirmed during inspection of the device and the device was confirmed to be functioning as intended after replacing carrying strap, battery pack, power supply and extension tubes.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 activecare +sft did not turn on and battery doesn't charge.No patient involved.Investigation relayed the ac/dc adapter right ac pin was broken and the wiring was exposed near dc connector.No adverse events were reported as a result of this malfunction.

• Brand Name: ACTIVECARE +SFT SYSTEM WARNING:
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• 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: 8712135
• MDR Text Key: 149368497
• Report Number: 0001526350-2019-00495
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: A502B000101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• 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