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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 AND ACCESSORIES

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SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.045S
Device Problem Break (1069)
Patient Problems Pain (1994); Non-union Bone Fracture (2369); Unspecified Tissue Injury (4559)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j sales representative. 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) 2021, the patient, who was injured on (b)(6) 2021, and treated with external fixation underwent the open reduction internal fixation surgery for trochanteric femur fracture with the tnfa-nail in question. After the surgery, on (b)(6) 2021, the patient underwent the plastic surgical flap operation. The patient was fully weight-bearing on (b)(6) 2021. The patient complained of pain on (b)(6) 2021. The surgeon confirmed broken nail and nonunion on an x-ray on (b)(6) 2021. The patient underwent reoperation, to replace tfna long nails on (b)(6) 2021. The surgeon suggested that the large bone was damage, soft tissue injury, and the delayed weight bearing due to multiple traumas were involved. Procedure was completed successfully without any surgical delay. 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 AND ACCESSORIES
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12370784
MDR Text Key268247740
Report Number8030965-2021-07226
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
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 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.045S
Device Lot Number51P3830
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 Received10/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/26/2021 Patient Sequence Number: 1
Treatment
UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
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