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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.038.205S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/12/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a (b)(6) sales representative. 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 a revision surgery to convert a trochanteric fixation nail-advanced (tfna) nail right long "11mmx420mm with 105mm screw to a shorter nail. During the revision procedure, 420mm nail, screw and distal locking screws were removed. During insertion of the new screw for the new tfna 380mmx12mm, the screw was measured again at 105mm. Surgeon planned to use same hole made by previous screw, therefore lateral cortex opened, step reamer and tap was declined to be used as a previous hole was noted to exist. While inserting the screw surgeon noted bone was very dense and surgeon struggled to advance the screw. Surgeon attempted to back out screw to reassess, however during this extraction the approximately 50% of the threads of the screw broke off. The surgeon was unable to remove the fragments and completed the revision with a 90mm helical blade. There was surgical delay of approximately twenty (20) minutes due to an attempt to remove the screw fragments. Patient consequences are unknown. No further information provided. This report is for one (1) tfna fenestrated screw 105mm - sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameTFNA FENESTRATED SCREW 105MM - 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 Key11798600
MDR Text Key262151064
Report Number2939274-2021-02280
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.205S
Device Catalogue Number04.038.205S
Device Lot Number48P8670
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 Received05/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2020
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: 05/10/2021 Patient Sequence Number: 1
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