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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/135 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/135 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.272S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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
It was reported that on (b)(6) 2021, during a trochanteric femoral nailing advanced (tfna) procedure intramedullary (im) nailing of femur, the set screw was not put down, and instead reversed until it bound itself against the connecting screw of the tfna insertion handle. Consequently, the surgeon planned to leave it as is, but when attempting to remove the connecting screw, it would not budge. As a result, the tfna screw was removed (no 5. 0mm locking screw was used) and trochanteric femoral nailing advanced (tfna) nail (still attached to the insertion handle) was removed. Then a new nail was opened and attached to a tfna hybrid handle. Surgeon reinserted the nail and finished the procedure with no further problems. Now the old nail is stuck to the insertions handle for tfna. The procedure was successfully completed with thirty (30) minutes surgical delay reported. No patient consequence reported. This report is for one (1) 12mm/135 deg ti cann tfna 170mm - sterile. This is report 1 of 3 for complaint (b)(4).
 
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Brand Name12MM/135 DEG TI CANN TFNA 170MM - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12350510
MDR Text Key267653826
Report Number2939274-2021-04785
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.272S
Device Catalogue Number04.037.272S
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 Received07/22/2021
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

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