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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC SPIRAL BLADE F/EXPERT RFN L75 TAN GOLD ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE: SYNTHES USA PRODUCTS LLC SPIRAL BLADE F/EXPERT RFN L75 TAN GOLD ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.013.047
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Type  Injury  
Manufacturer Narrative
Add'l narrative: patient weight reported as (b)(6) it is unknown if that is (b)(6) pounds or kilograms. Part 04. 013. 047, lot h052871: date of manufacture: march 02, 2016. Place of manufacture: (b)(4). A review of the device history record revealed no complaint related anomalies. The device history record shows this lot of ti spiral blade 75mm for ti retrograde femoral nails ¿ ex nonsterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. Corrected data: initially reported as (b)(6) 2017 but should have been (b)(6) 2017. 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.
 
Manufacturer Narrative
Patient information is unknown. Date of event: it is unknown when the event occurred. Additional procode hwc. Product investigation has not been completed; no conclusion could be drawn, as no product was received. A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition. No ncrs were generated during the production of this device. 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 hindfoot nail was implanted on (b)(6) 2017 in a diabetic patient. Eventually skin necrosed over spiral blade site and hardware was exposed. So a revision surgery was performed on (b)(6) 2017 to remove the blade and the wound was treated with a vacuum-assisted closure. The procedure was successfully completed with no surgical delay and the patient was stable after the surgery. This complaint involves one (1) device. This report is for a helical blade. This is 1 of 1 for (b)(4).
 
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Brand NameSPIRAL BLADE F/EXPERT RFN L75 TAN GOLD
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)
ELMIRA
35 airport road
horseheads NY
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
MDR Report Key7176615
MDR Text Key112600084
Report Number2939274-2018-50139
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K033618
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.013.047
Device Catalogue Number04.013.047
Device Lot NumberH052871
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 Received01/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/02/2016
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: 01/09/2018 Patient Sequence Number: 1
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