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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.230S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Pain (1994)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022, the surgeon removed a tfna nail to convert the patient to a total hip. Patient was in pain and has arthritis of her hip. All tfna implants were removed successfully. Procedure was successfully completed. This report is for one (1) 12mm/125 deg ti cann tfna 400mm/right - sterile. This is report 1 of 4 for complaint (b)(4).
 
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was conducted: part # 04. 037. 230s, synthes lot # h660112, supplier lot # n/a, release to warehouse date: 13 jun 2018, manufactured by: (b)(4), no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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.
 
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Brand Name12MM/125 DEG TI CANN TFNA 400MM/RIGHT - 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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13620538
MDR Text Key286253990
Report Number2939274-2022-00685
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.037.230S
Device Catalogue Number04.037.230S
Device Lot NumberH660112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2018
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/28/2022 Patient Sequence Number: 1
Treatment
5.0 TI LOCKING SCREW 80- FOR IM NAILS; LOCKSCR Ø5 SELF-TAP L48 TAN; TFNA SCREW 85MM
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