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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.124S
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: 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 underwent open reduction internal fixation surgery for right trochanteric fracture. After inserting a reaming rod into the intrathecal space, the surgeon confirmed whether the reaming rod was placed in the middle of the intrathecal space by image intensifier. The surgeon then performed reaming with the nail and there was a slight resistance when the nail was inserted. Hammering was also performed, and the surgeon completed the nail insertion. When the surgeon inserted a blade and moved to the insertion procedure of a locking screw, the anterior penetration of the nail end was confirmed. The nail was removed and replaced with another shorter nail. The surgery was completed with a thirty (30) minute delay. This report is for one (1) 11mm/125 deg ti cann tfna 340mm/right - sterile. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
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 underwent open reduction internal fixation surgery for right trochanteric fracture. After inserting a reaming rod into the intrathecal space, the surgeon confirmed whether the reaming rod was placed in the middle of the intrathecal space by image intensifier. The surgeon then performed reaming with the nail and there was a slight resistance when the nail was inserted. Hammering was also performed, and the surgeon completed the nail insertion. When the surgeon inserted a blade and moved to the insertion procedure of a locking screw, the anterior penetration of the nail end was confirmed. The nail was removed and replaced with another shorter nail. The surgery was completed with a thirty (30) minute delay. This report is for one (1) 11mm/125 deg ti cann tfna 340mm/right - sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/125 DEG TI CANN TFNA 340MM/RIGHT - 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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13152965
MDR Text Key286261616
Report Number8030965-2022-00026
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.124S
Device Lot NumberH402024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2017
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/04/2022 Patient Sequence Number: 1
Treatment
UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - REAMERS; UNK - REAMING RODS; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING
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