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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 4.5MM TI MULTILOC SCREW 4.5MM TI MULTILOC SCREW ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA 4.5MM TI MULTILOC SCREW 4.5MM TI MULTILOC SCREW ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.019.016
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2016
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment, not diagnosis. (b)(4). Device is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes on an event in (b)(6) as follows: it was reported that a surgery for upper arm proximal fracture was performed on (b)(6) 2016. The patient had two parts of surgical neck fractured. Although the patient was small, the surgeon determined to use a multiloc screw. He fixed temporarily as he detained two drill bits. He then inserted the multiloc screw in the proximal d-hole but the screw was off the target area. He also checked the distal, and the drills were also off the targeted area. The surgery was prolonged about 20 minutes. No information about patient condition and outcome available. This complaint involves 2 parts. Concomitant reported part: 1x multiloc proximal humeral nail (part 04. 016. 035s lot unknown). This report is 1 of 2 for (b)(4).
 
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Brand Name4.5MM TI MULTILOC SCREW 4.5MM TI MULTILOC SCREW
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6168427
MDR Text Key62389113
Report Number2520274-2016-15664
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
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 11/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.016
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 Received11/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/12/2016 Patient Sequence Number: 1
Treatment
04.016.035S, 1X MULTILOC PROXIMAL HUMERAL NAIL
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