MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. H.A.S. KIT WITH 3/16" DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number 00255503005

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a hair was noticed inside the package while preparing for surgery.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record (dhr) for the h.A.S.Kit with 3/16 in.Drain, part number 00255503005 and lot number 63476613, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 09 dec 2017, it was reported from cypress pointe that five h.A.S.Kits with 3/16 in.Drain had a hair inside the packaging.On 02 jan 2018, a returned product investigation was performed on the h.A.S.Kits with 3/16 in.Drain.The physical evaluation revealed that one of the returned h.A.S.Kits had a hair inside the opened packaging.The other four kits that were returned were unopen and no foreign objects were found inside the packaging.The results of the returned product investigation for the four unopened kits cannot be confirmed because no foreign object was found inside the packaging.The result of the one opened kit also cannot be confirmed because the sterile barrier was broken by the account prior to returning for evaluation and is therefore non-verifiable.The root cause of the reported event cannot be specifically determined with the provided information because reported event was not able to be reproduced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: H.A.S. KIT WITH 3/16" DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: 7137853
• MDR Text Key: 96041011
• Report Number: 0001526350-2017-01002
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK920273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 00255503005
• Device Lot Number: 63476613
• Other Device ID Number: (01) 00889024021570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1