Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 POSITIONING GUIDE ROD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. G7 POSITIONING GUIDE ROD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign country: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during the surgery, it was found that the tip of this complaint rod was fractured before use.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
Upon reassessment of the reported event, the g7 positioning guide rod was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, the g7 positioning guide rod was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
G7 POSITIONING GUIDE ROD
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11047170
MDR Text Key222810597
Report Number0001825034-2020-04388
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number110018822
Device Lot NumberZB150701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-