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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X30MM CORT LOCK SCR STE; PLATE, FIXATION, BONE
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ZIMMER BIOMET, INC. 3.5X30MM CORT LOCK SCR STE; PLATE, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign 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.
 
Event Description
It was reported that the incoming inspection team member found debris in the sterile package.No further information is available at this time.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The sterility did not compromise as a result of this event.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The sterility did not compromise as a result of this event.The initial report was forwarded in error and should be voided.
 
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Brand Name
3.5X30MM CORT LOCK SCR STE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9165876
MDR Text Key200421485
Report Number0001825034-2019-04542
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K143697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number856135030
Device Lot Number212770
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Was the Report Sent to FDA? No
Date Manufacturer Received12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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