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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO NL 3CM DIASL CNCTR ROD, FIXATION

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ZIMMER BIOMET, INC. MOD ARTHRO NL 3CM DIASL CNCTR ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Component Missing (2306); Out-Of-Box Failure (2311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Reported event was confirmed. Transaction quantities confirmed that these components were not issued and that this event was a one off. Review of device history records found these units were released to distribution with no deviations or anomalies. Review of complaint history found no additional related issues for this item. Completion of investigation relayed to sales rep via phone. 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. (b)(4).
 
Event Description
It was reported that during a total knee resection utilizing an oss modular arthrodesis nail, the locking screw was missing from the packaging. There was no delay in the procedure as the surgeon did not require the screw for the procedure. Competitor implants were removed due to infection. No additional patient consequences were reported. Attempts have been made and no further information has been provided.
 
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Brand NameMOD ARTHRO NL 3CM DIASL CNCTR
Type of DeviceROD, FIXATION
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 Key6930861
MDR Text Key89954269
Report Number0001825034-2017-08252
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK042409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 10/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP260607
Device Lot Number181570
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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