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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GRENCHEN 4.5MM TI MULTILOC SCREW LENGTH 38MM ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GRENCHEN 4.5MM TI MULTILOC SCREW LENGTH 38MM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.019.038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sedation (2368); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Brand name correction. 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
Device used for treatment, not diagnosis. Patient age, dob gender & weight not available for reporting. Udi: (b)(4) lot number is unknown. Device malfunctioned intra-operatively and was not implanted / explanted device is not expected to be returned for manufacturer review/investigation. The reported event required medical/surgical intervention to preclude permanent damage to a body structure. 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 during a humeral fracture fixation, using a multiloc nail, after they insert the a multiloc screw, they needed to adjust its position, while doing so, they pushed the screw and it went through from the other side of the nail, they managed to take it out after an hour delay. No reported adverse event to patient. This complaint involves one parts. This report is 1 of 1 for (b)(4).
 
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Brand Name4.5MM TI MULTILOC SCREW LENGTH 38MM
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GRENCHEN
solothurnstrasse 186
grenchen CH254 0
SZ CH2540
Manufacturer (Section G)
SYNTHES GRENCHEN
solothurnstrasse 186
grenchen CH254 0
SZ CH2540
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6822234
MDR Text Key250610870
Report Number3009450884-2017-10110
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.019.038
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 Received08/25/2017
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: 08/25/2017 Patient Sequence Number: 1
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