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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 / TI CANN FRN / GT 360 / LEFT - SILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 / TI CANN FRN / GT 360 / LEFT - SILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.033.967S
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Event Description
It was reported on (b)(6) 2022, during a routine frn nail insertion, the im nail got stuck in the canal of the femur. The canal 1. 5mm reamed over the nail diameter and opened the proximal segment with the appropriate 14mm drill bit from the set. The nail became incarcerated upon insertion and the proximal body of the nail seemed to be too long for the proximal segment of the femur on this patient. The driving cap broke off leaving a fragment in the insertion handle due to incarceration that led the surgeon to have to strike the insertion handle to seat the nail. The surgeon determined that the nail was finally seated to a depth after a 30 min delay. Standard locking of the proximal and distal nail occurred without incident. This report is for one (1) 9 / ti cann frn / gt 360 / left - sile. This is report 2 of 2 for complaint (b)(4).
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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.
 
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Brand Name9 / TI CANN FRN / GT 360 / LEFT - SILE
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14254562
MDR Text Key290449475
Report Number2939274-2022-01570
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.033.967S
Device Catalogue Number04.033.967S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
Treatment
DRIVING CAP/THREADED.; RADIOLUCENT INSERTION HANDLE FRN; UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL PROXIMAL LOCKING.
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