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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK DIST TIB MED LT 6H STE; PLATE, FIXATION
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ZIMMER BIOMET, INC. LOCK DIST TIB MED LT 6H STE; PLATE, FIXATION Back to Search Results
Model Number 8562-11-006
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2022
Event Type  malfunction  
Event Description
It was reported during the incoming inspection at warehouse that the sterile package was not vacuumed.No adverse event has been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).Concomitant medical devices: 856210009 950980 lock dist tib med rt 9h ste, 856210009 950980 lock dist tib med rt 9h ste, 856211006 045420 lock dist tib med lt 6h ste.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -  2022 -  02556, 0001825034 -  2022 -  02558, 0001825034 -  2022 -  02559.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.The initial report was forwarded in error and should be voided.
 
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Brand Name
LOCK DIST TIB MED LT 6H STE
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key15779108
MDR Text Key307776133
Report Number0001825034-2022-02557
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00887868062087
UDI-Public(01)00887868062087(17)320522(10)045420
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8562-11-006
Device Catalogue Number856211006
Device Lot Number045420
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2022
Date Device Manufactured05/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
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