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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM NAIL TROCH RT 10.5MMX400MM; PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. FEM NAIL TROCH RT 10.5MMX400MM; PROSTHESIS, TRAUMA Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Complaint sample was evaluated and the reported event was confirmed.The sample part was reviewed and observed to have punctured through the packaging barrier system which occurred during shipping.The packaging bom has been changed to provide more protection and hold the product in place.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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
It was reported that the packaging was discovered to be torn during a right femoral nail surgery.A different nail was used to complete the procedure without delay.No adverse events have been reported as a result of the malfunction.
 
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Brand Name
FEM NAIL TROCH RT 10.5MMX400MM
Type of Device
PROSTHESIS, TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6954081
MDR Text Key90459289
Report Number0001825034-2017-08787
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
PK072161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/17/2017
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 Expiration Date12/31/2018
Device Model NumberN/A
Device Catalogue Number14-443440
Device Lot Number695750
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/11/2015
Initial Date FDA Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
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