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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN A/R SCREW 75MM TRAUMA, IMPLANT

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ZIMMER BIOMET, INC. HFN A/R SCREW 75MM TRAUMA, IMPLANT Back to Search Results
Model Number N/A
Device Problems Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: foreign: event occurred in (b)(6). 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 the incoming inspection team member found debris in the sterile package. No patient involvement.
 
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Brand NameHFN A/R SCREW 75MM
Type of DeviceTRAUMA, IMPLANT
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 Key10472227
MDR Text Key206390564
Report Number0001825034-2020-03152
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814501075
Device Lot NumberWG1112275C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

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