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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 Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2021
Event Type  malfunction  
Manufacturer Narrative
(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 report will be submitted.
 
Event Description
It was reported that during incoming inspection, it was noted that there was a scratch on the sterile package.There was no patient involvement.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h10 upon further review of the returned product it has been determined that the reported device did not cause or contribute to the event as the sterile barrier was not breached.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.
 
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Brand Name
LOCK SCREW SQ 2.7MM 16MM STE
Type of Device
SCREW, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11464700
MDR Text Key239255748
Report Number0001825034-2021-00735
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K112345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number131827116
Device Lot Number996540
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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