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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.045S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2020. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery where cephalic screw and tfna nail were implanted. Five (5) months later, the patient presented to the doctor's office with pain. An x-ray showed the split nail. On (b)(6) 2020 revision surgery was performed to extract the tfna nail due to implant failure as the nail split in the cephalic part. The surgeon repositioned a new tfna nail and lag screw. It was reported that the nail broke within the patient three (3) months after placement. No further information was provided. This report is for one (1) 10mm/130 deg ti cann tfna 235mm/left - sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10803200
MDR Text Key217428836
Report Number8030965-2020-08716
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K160167
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 10/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.045S
Device Catalogue Number04.037.045S
Device Lot Number10L0839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2019
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: 11/06/2020 Patient Sequence Number: 1
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