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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X16MM LOW PRO CORT SCR STE PLATE, FIXATION/TRAUMA

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ZIMMER BIOMET, INC. 3.5X16MM LOW PRO CORT SCR STE PLATE, FIXATION/TRAUMA Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source: (b)(6). Visual examination of the returned product found a unknown stain/debris in the sterile packaging. Review of the device history record(s) identified no deviations or anomalies during manufacturing. Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review. The root cause of the reported event is the operator not following the work instructions provided. 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 during inspection in warehouse product was found to have a stain in the sterile packaging.

 
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Brand Name3.5X16MM LOW PRO CORT SCR STE
Type of DevicePLATE, FIXATION/TRAUMA
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 Key12202527
MDR Text Key262665373
Report Number0001825034-2021-02146
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
Report Date 07/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number851235016
Device LOT Number449480
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/28/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/16/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/20/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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