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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL GUIDE WIRE BALL TIP 2.4 MM DIAMETER 70 CM LENGTH SHOULDER, INSTRUMENT

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ZIMMER BIOMET, INC. HUMERAL GUIDE WIRE BALL TIP 2.4 MM DIAMETER 70 CM LENGTH SHOULDER, INSTRUMENT Back to Search Results
Catalog Number 47225500800
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign: (b)(6). 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 report will be submitted. Product not returned.
 
Event Description
It was reported that during an inspection at the warehouse, the packaging on the sterile products were found to be opened. There was no patient involvement.
 
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Brand NameHUMERAL GUIDE WIRE BALL TIP 2.4 MM DIAMETER 70 CM LENGTH
Type of DeviceSHOULDER, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key11048002
MDR Text Key222789321
Report Number0001822565-2020-04172
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47225500800
Device Lot Number64456097
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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