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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 ALFN; ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT RECON AIMING ARM FOR EXPERT ALFN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.010.483
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter¿s phone number is not provided for reporting.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 during femur open reduction and internal fixation (orif) performed on (b)(6) 2018 for an unknown patient the surgeon was assembling the adolescent lateral femoral nail (alfn) when it was noted the proximal interlocks weren¿t lining up in the nail through the aiming assembly.The drill was completely missing the nail through the aiming assembly.After the case, the sales consultant inspected the devices and noted the aiming arm to be loose.The aiming arm and connecting arm had some play when fully seated due to wear and tear and the connecting arm to be chipped on the metal clips that connect to the nail.These devices were not used on the patient during the surgery.The surgeon completed the procedure by doing perfect circles.There was no reported surgical delay and no reported patient consequence.Concomitant devices reported: insertion instrument: coupling screw (part # unknown, lot # unknown, quantity 1); alfn nail (part # unknown, lot # unknown, quantity 1).This report is for one (1) radiolucent recon aiming arm for expert alfn.This is report 2 of 2 for complaint (b)(4).
 
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Brand Name
RADIOLUCENT RECON AIMING ARM FOR EXPERT ALFN
Type of Device
ROD, 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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7498364
MDR Text Key107863414
Report Number2939274-2018-52105
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982069016
UDI-Public(01)10886982069016
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.010.483
Device Catalogue Number03.010.483
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/11/2018
Initial Date FDA Received05/09/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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