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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X32MM CORTICAL SCREW STE ROD, FIXATION

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ZIMMER BIOMET, INC. 3.5X32MM CORTICAL SCREW STE ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Unsealed Device Packaging (1444); Out-Of-Box Failure (2311); Incomplete or Missing Packaging (2312)
Patient Problem No Patient Involvement (2645)
Event Date 06/17/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Complaint sample was evaluated and the reported event was confirmed. The evaluation stated the goods were signed in as ok by receiver. The products left biomet control in a conforming state. We utilize standard size boxes for all our outer packaging and personnel are trained to a standard operating procedure. Upon review of internal standard where the stipulation is "product shall be packed into suitable transit packaging so that adequate protection may be afforded to the product during transit to the customer" which is always the case. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. "product shall be packed into suitable transit packaging so that adequate protection may be afforded to the product during transit to the customer. " 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. 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
It was reported that implants were damaged upon delivery. Items inside were damaged, some of the package seals were damaged although not all the cellophane wraps were damaged. One item was completely open on cellophane and outer box wrap. Only three or four screws were not damaged.
 
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Brand Name3.5X32MM CORTICAL SCREW STE
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 Key6910187
MDR Text Key89464050
Report Number0001825034-2017-07681
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number850535032
Device Lot NumberHD4A95
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2013
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

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