• 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. UNKNOWN PIN; INSTRUMENT, KNEE

  • 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. UNKNOWN PIN; INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05603 and 0001822565-2019-05330.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 a knee procedure, a drill pin was cross-threaded in a cut guide and became stuck.It could not be removed from the cutting block.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The pin is fractured and exhibits signs of repeated use.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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
No further event information available at the time of this report.
 
Event Description
This follow-up report is being filed to relay that the previous report submitted was submitted erroneously under the wrong manufacturing report number.
 
Manufacturer Narrative
This follow-up report is being filed to relay that the previous report submitted was submitted erroneously under the wrong manufacturing report number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN PIN
Type of Device
INSTRUMENT, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9481273
MDR Text Key189989425
Report Number0001822565-2019-05330
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 05/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/17/2019
Supplement Dates Manufacturer Received05/27/2020
05/24/2021
Supplement Dates FDA Received05/28/2020
05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-