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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW SQ 2.7MM 18MM STE PLATE, FIXATION

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ZIMMER BIOMET, INC. LOCK SCREW SQ 2.7MM 18MM STE PLATE, FIXATION Back to Search Results
Model Number 131827118
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
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 mdr will be submitted.

 
Event Description

It was reported that the incoming inspection team member found debris in the sterile package. There was no patient or surgical involvement at the time of the event.

 
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Brand NameLOCK SCREW SQ 2.7MM 18MM STE
Type of DevicePLATE, 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 Key11789752
MDR Text Key249481304
Report Number0001825034-2021-01230
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK112345
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 06/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/07/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number131827118
Device Catalogue Number131827118
Device LOT Number983620
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2020
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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