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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.010.482
Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional medical/surgical intervention required and change in surgical plan: unable to proceed with the recon nail locking option). The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 during a recon nail surgery on (b)(6) 2019, the cannulas of two (2) radiolucent recon aiming arm for expert lateral femoral nail (lfn) were a little bit loose inside. The four (4) guide wires missed the recon nail hole posterior and anterior by quite a bit and because of it surgeon was unable to proceed with the recon nail locking option. Even after locking the largest gold cannula into the radiolucent aiming arm, the surgeon and the sales rep felt as though there was some "wiggle" room or a little bit of toggle that could be the cause of the guidewires missing the nail's recon holes. A few millimeters of toggle could create a misplaced guide wire. There was a surgical delay of 5-8 minutes. The surgery was completed using the same aiming arms and the standard locking option for the patient. It was an impending fracture distally down the shaft of the femur, so nothing was compromised. The patient outcome is unknown. Concomitant devices reported: unknown recon nail (part# unknown, lot# unknown, quantity# 1). This report is for one (1) radiolucent recon aiming arm. This is report 1 of 6 for complaint (b)(4).
 
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Brand NameRADIOLUCENT RECON AIMING ARM FOR EXPERT LFN
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)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8945814
MDR Text Key160440786
Report Number2939274-2019-60208
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040336
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
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.010.482
Device Catalogue Number03.010.482
Device Lot NumberT993311
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/29/2019 Patient Sequence Number: 1
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