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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X26MM LOW PRO CORT SCR STE SCREW, FIXATION

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ZIMMER BIOMET, INC. 3.5X26MM LOW PRO CORT SCR STE SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 02/03/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source: (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 there was debris in the sterile package. No patient involvement.

 
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Brand Name3.5X26MM LOW PRO CORT SCR STE
Type of DeviceSCREW, FIXATION
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 Key9749704
MDR Text Key200694248
Report Number0001825034-2020-00696
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberN/A
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 06/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number851235026
Device LOT Number179640
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 Received06/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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