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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. 4.0 MM CANCELLOUS SCREW PARTIALLY THREADED; PLATE, FIXATION
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ZIMMER MANUFACTURING B.V. 4.0 MM CANCELLOUS SCREW PARTIALLY THREADED; PLATE, FIXATION Back to Search Results
Catalog Number 47484003501
Device Problem Unintended Movement (3026)
Patient Problem Unspecified Infection (1930)
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length pn: 47235701806 ln: 63550687; 2.7 mm locking screw 14 mm length pn: 47482801402 ln: 63671062; 2.7 mm locking screw 16 mm length pn: 47482801602 ln: 63869781; 2.7 mm locking screw 12 mm length pn: 47482801202 ln: 63861780; 2.7mm locking screw 12mm long pn: unk ln: 62348896; 2.7 mm locking screw 18 mm length pn: 47482801802 ln: 63861772; cortical bone screw self-tapping hex head 3.5 mm diameter 18 mm length pn: 47234801835 ln: 63098016; cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688; cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688; cortical bone screw self-tapping hex head 3.5 mm diameter 40 mm length pn: 47234804035 ln: 61168845.Report source: foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00655, 0001822565-2019-00656, 0001822565-2019-00657, 0001822565-2019-00658, 0001822565-2019-00659, 0001822565-2019-00660, 0001822565-2019-00662, 0001822565-2019-00663, 0001822565-2019-00664, 0002648920-2019-00109.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a revision due to screw backing out and alleged infection.However, there was no growth from three samples.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Udi # - (b)(4).Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length pn: 47235701806 ln: 63550687 2.7 mm locking screw 14 mm length pn: 47482801402 ln: 63671062 2.7 mm locking screw 16 mm length pn: 47482801602 ln: 63869781 2.7 mm locking screw 16 mm length pn: 47482801602 ln: 63861780 4.0 mm cancellous screw partially threaded 35 mm length pn: 47484003501 ln: 61234509 2.7 mm locking screw 18 mm length pn: 47482801802 ln: 63861772 cortical bone screw self-tapping hex head 3.5 mm diameter 18 mm length pn: 47234801835 ln: 63098016 cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688 cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688 cortical bone screw self-tapping hex head 3.5 mm diameter 40 mm length pn: 47234804035 ln: 61168845 4.0 mm cancellous screw partially threaded 35 mm length pn: 47484003501 ln: 63258244.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.
 
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Brand Name
4.0 MM CANCELLOUS SCREW PARTIALLY THREADED
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key8349441
MDR Text Key136490457
Report Number0002648920-2019-00108
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
K111447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number47484003501
Device Lot Number63258244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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