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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.165S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Discomfort (2330); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 an unknown date, the patient was scheduled to undergo a replacement of 105mm helical blade but they noticed that the trochanteric fixation nail-advanced (tfna) was broken at the nail junction blade interface. Both the nail and helical blade were removed and replaced. There was no patient consequence reported. Surgical procedure delay and patient outcome is unknown. Concomitant devices reported: distal locking screw (part/lot unknown, quantity unknown); tfna blade (part 04. 038. 305s, lot unknown, quantity 1) this report is for a tfna nail. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
(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) 2018, the patient was scheduled to undergo a replacement of 105mm helical blade due to discomfort in the patient. When the blade was removed, it was noticed the trochanteric fixation nail-advanced (tfna) was broken at the nail junction blade interface. Both the nail and helical blade were removed and replaced. There was no patient consequence reported. Surgical outcome is unknown. Concomitant devices: distal locking screw (part: unknown, lot: unknown, quantity: unknown), tfna blade (part: 04. 038. 305s, lot: unknown, quantity: 1).
 
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Brand Name11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7930333
MDR Text Key122511559
Report Number2939274-2018-54119
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.165S
Device Catalogue Number04.037.165S
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 Received10/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/03/2018 Patient Sequence Number: 1
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