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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 456.476S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative
Patient information is unknown. Additional procode: hwc. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter email address is unavailable. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history records review has been requested. (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 the patient underwent hip surgery on (b)(6) 2018. During the procedure, the helical blade did not pass through the trochanteric fixation nail system (tfn) on back table when testing the nail prior to insertion into patient. This resulted in the use of the tfn-advanced proximal femoral nailing system (tfna) intraoperatively. Postoperatively, the surgery team came to realize that out of the sterile packaging, the set screw was engaged too far into the nail, engaging the locking mechanism in the nail and preventing the helical blade from passing. The set screw needed to be dialed back a few turns in order the for the blade to pass. It is unknown if there was surgical delay. Patient outcome is unknown. Concomitant devices: tfn helical blade (part: unknown, lot: unknown, quantity: 1), trauma screw (part: unknown, lot: unknown, quantity: 1). This report is for a 12mm/130 deg titanium (ti) cann troch fixation nail 360mm/right-ster. This is report 1 of 1 for (b)(4).
 
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Brand Name12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7626773
MDR Text Key111938485
Report Number2939274-2018-52580
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number456.476S
Device Catalogue Number456.476S
Device Lot Number9850781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/21/2018 Patient Sequence Number: 1
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