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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.042S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Manufacturing location: monument. Manufacturing date: 31-oct-2018. Expiration date: 30-sep-2028. Part number: 04. 037. 042s, 10mm/130 deg ti cann tfna 170mm ¿ sterile. Lot number: h767611 (sterile). Lot quantity: 6. Work order traveler met all inspection acceptance criteria. Inspection sheet, in process / inspect dimensional / final met all inspection acceptance criteria. Inspection sheet, tfna assembly inspection met all inspection acceptance criteria. Packaging label log (pll) was reviewed and determined to be conforming. Scn 15643 supplied by ees (albuquerque) was reviewed and determined to be conforming. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to hip arthritis¿ does not indicate breakage of the nail or any of its components. Therefore review of the raw materials would not be pertinent to the reported complaint condition. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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. (b)(4). 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) 2020 the patient underwent the removal of proximal femoral nailing system (tfna) implants due to hip arthritis and decreased range of motion (rom). The patient was then revised with a total hip arthroplasty. The procedure was successfully completed. The patient outcome is stable. This report is for 1 10mm/130 deg ti cann tfna 170mm-sterile. This is report 1 of 3 for (b)(4).
 
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Brand Name10MM/130 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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10465605
MDR Text Key204745362
Report Number2939274-2020-03858
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.037.042S
Device Catalogue Number04.037.042S
Device Lot NumberH767611
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 Received08/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2018
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: 08/28/2020 Patient Sequence Number: 1
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