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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW SQ 2.7MM 16MM STE SCREW, FIXATION

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ZIMMER BIOMET, INC. LOCK SCREW SQ 2.7MM 16MM STE SCREW, FIXATION Back to Search Results
Catalog Number 131827116
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 08/03/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Udi#: (b)(4). Report source: (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. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that incoming inspection team member found debris in sterile packaging. No adverse event has been reported as a result of the malfunction.

 
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Brand NameLOCK SCREW SQ 2.7MM 16MM 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 Key10393225
MDR Text Key202738530
Report Number0001825034-2020-03076
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 DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number131827116
Device LOT Number884170
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/11/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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