MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. TOTAL SHIELD BATTERY HOLSTER; PROTECTIVE APPAREL

Catalog Number 00990010400

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that a piece of plastic was broken on the bottom of the device exposing wires.Damage occurred while not in surgery.No harm or delay reported with this event.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed as a correction report.The device was initially reported for exposed wires.Upon device evaluation there were no bare/ exposed wires.The following sections were updated/corrected: b4, b5, g4, g7, h2, h3, and h10.

Event Description

No additional event information.

• Brand Name: TOTAL SHIELD BATTERY HOLSTER
• Type of Device: PROTECTIVE APPAREL
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9401044
• MDR Text Key: 191536789
• Report Number: 0001526350-2019-01092
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• PMA/PMN Number: K132386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00990010400
• Device Lot Number: WO140161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1