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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.030
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2018
Event Type  malfunction  
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. 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.
 
Event Description
It was reported that on (b)(6) 2018, patient underwent a removal of trochanteric fixation nail advanced (tfna) nail and blade due to painful non-union. It was further reported a distal locking screw was broken. Both pieces of the broken screw were removed. During the procedure, upon extracting the tfna helical blade, the extraction instrument for tfna helical blade and screw did not function properly. Surgeon had to use the helical blade/screw coupling screw to remove the blade. Surgeon also had difficulty engaging the extraction instrument for nails, cannulated to the top of the nail and stated that it is not tapped and very touchy to engaged into the nail. The extraction instrument for nails finally engaged and the nail was removed. The surgeon then proceeded to insert a competitor¿s nail and the surgery was completed with no issues. The revision due to non-union is addressed in (b)(4). This report addresses the intraoperative events with the instruments. Concomitant medical products: tfna nail (part 04. 037. 159, lot h513989, quantity 1). Helical blade (part 04. 037. 395, lot h458427, quantity 1). This report is for one (1) helical blade/screw extractor. This is report 1 of 3 for (b)(4).
 
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Brand NameHELICAL BLADE/SCREW EXTRACTOR
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)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8155476
MDR Text Key130329540
Report Number2939274-2018-55362
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
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 11/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.030
Device Catalogue Number03.037.030
Device Lot Number9837987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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