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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

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SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT Back to Search Results
Catalog Number 413.035
Device Problem Material Deformation (2976)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
Additional procode: ktt. Reporter is a synthes employee. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. (b)(4). Device was 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.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that the patient underwent an initial operation on march 3, 2021. The patient underwent a revision operation on (b)(6) 2021 due to a broken plate. The surgery was successfully completed and the patient was doing well. This report is for one (1) 3. 5mm ti locking screw self-tapping 35mm. This is report 4 of 5 for (b)(4).
 
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Brand Name3.5MM TI LOCKING SCREW SELF-TAPPING 35MM
Type of DeviceAPPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12385006
MDR Text Key268707677
Report Number8030965-2021-07345
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K011815
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 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number413.035
Device Lot Number66P5497
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2020
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: 08/30/2021 Patient Sequence Number: 1
Treatment
CONNECTION SCREW F/LOCKING ATTACHMENT PL; LCP-DF 4.5/5 LE 11HO L276 TAN; LOCKING ATTACHMENT PLATE 3.5 F/LCP 4.5/5; LOCKSCR Ø3.5 SELF-TAP L35 TAN; LOCKSCR Ø3.5 SELF-TAP L35 TAN; UNK - SCREWS: DISTAL FEMUR
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