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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE N/A

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SYNTHES USA 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE N/A Back to Search Results
Catalog Number 04.019.038S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 11/11/2016
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. (b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(6). (b)(4): the complainant reported bone fragment of proximal epiphysis started inverting and de-rolling. Then after one week, the surgeon noted a¿ falling image of the bone fragment". At the time of this review, it is unknown which implant penetrated the greater tubercle and there is no allegation of a device malfunction. Should further information become available this determination will be reviewed accordingly. 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
It was reported that a multiloc proximal humeral nail, three multiloc screws and two self-tapping locking screw were used in a surgery for proximal humeral surgical neck fracture on (b)(6) 2016. A surgeon could not use ascending screws because the patient was small. The surgeon used three multiloc screw (ø4. 5 l38 tan), a locking screw (ø3. 5 self-tap l30 tan) and a locking screw (ø3. 5 self-tap l32 tan). There was nothing wrong with an insertion portion of the nail. As he checked x-ray photography of the next day, he confirmed that bone fragment of proximal epiphysis started inverting and de-rolling. Then after one week, he confirmed a falling image of the bone fragment. The patient did not feel so much pain, probably because the patient has dementia. From ct images, he found a mark that the implant penetrated a greater tubercle. A surgery to remove the nail and replace it with an artificial shoulder bone head is planned on (b)(6) 2016. Complaint involves 6 parts. This report is 2 of 6 for (b)(4).
 
Manufacturer Narrative
Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4). Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE
Type of DeviceN/A
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6149978
MDR Text Key61589473
Report Number2520274-2016-15603
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 11/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.019.038S
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 Received12/13/2016
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: 12/06/2016 Patient Sequence Number: 1
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