MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 34IN. (86CM) DISPOSABLE CUFF W/PLC - DP, SB; CUFFS, TOURNIQUET, DISPOSABLE

Model Number N/A

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for the 34 in.(86cm) dual port single bladder disposable cuff with plc, part number 60707010600, review could not be performed as a lot number was not provided for the reported event.On (b)(6) 2017, it was reported from (b)(6) hospital that a 34 in.(86cm) dual port single bladder disposable cuff with plc partially deflated prior to completion of the surgery.On 03 feb 2017, a returned product investigation was performed on the 34 in.(86cm) dual port single bladder disposable cuff with plc.The physical evaluation revealed that the returned cuff was deflating due to a leak at the ports.The results of the returned product investigation can confirm the reported event.While the returned product investigation confirmed that the 34 in.(86cm) dual port single bladder disposable cuff with plc was leaking, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.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 cuff partially deflated prior to completion of case.No adverse events were reported as a result of this malfunction.The physical evaluation during investigation revealed that the returned cuff was deflating due to a leak at the ports.

• Brand Name: 34IN. (86CM) DISPOSABLE CUFF W/PLC - DP, SB
• Type of Device: CUFFS, TOURNIQUET, DISPOSABLE
• 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: 6813457
• MDR Text Key: 83643669
• Report Number: 0001526350-2017-00569
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 60707010600
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1