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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MEASURING DRILL SLEEVE STE TRAUMA DISPOSABLES

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ZIMMER BIOMET, INC. MEASURING DRILL SLEEVE STE TRAUMA DISPOSABLES Back to Search Results
Model Number N/A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 12/24/2015
Event Type  malfunction  
Manufacturer Narrative
Product has been received by zimmer biomet. Upon evaluation the complaint was confirmed as there two (2) small particles found inside of the sterile packaging but out side of the non-barrier poly pouch. The amount of the debris within the packaging did not exceed three (3) pieces but it was greater than 0. 4mm^2 in size. Therefore this product was non-conforming when it left zimmer biomet control. The debris is likely residual polyethylene left from manufacturing the non-barrier poly pouch that was not removed prior to packaging in the sterile pouch. Review of complaint history found no additional related issues for this item. Review of device history records found these units were released to distribution with no deviations or anomalies. 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. This report is being submitted late as it has been identified in remediation.
 
Event Description
It was reported that upon inspection at zimmer biomet (b)(4) on december 24, 2015, there was debris found in the packaging of a measuring drill sleeve. There was no patient involvement.
 
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Brand NameMEASURING DRILL SLEEVE STE
Type of DeviceTRAUMA DISPOSABLES
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 Key6945049
MDR Text Key90328962
Report Number0001825034-2017-08591
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number856301005
Device Lot Number990620
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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