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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 400MM / RIGHT ¿ STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 400MM / RIGHT ¿ STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.033.070S
Device Problem Use of Device Problem (1670)
Patient Problem Not Applicable (3189)
Event Date 06/28/2018
Event Type  Injury  
Manufacturer Narrative
Device was not explanted. 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 patient underwent a procedure to implant a 10mm cannulated femoral recon nail (frn) on (b)(6) 2018. During the procedure, the nail became lodged in the patient¿s proximal femur, as the opening reamer of the nail did not allow for the nail to be fully inserted. Surgeon attempted to back the nail out but was not successful. Surgeon was forced to proceed with insertion of the nail and was eventually able to seat the nail, but only low enough to allow for one (1) proximal femoral recon screw to be implanted. Surgeon was then able to use the nail¿s distal locking options to complete the procedure with a delay of approximately 60 minutes. This report is for one (1) 10mm cannulated frn nail. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM / TI CANN FRN / GT 400MM / RIGHT ¿ 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)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7716182
MDR Text Key114934363
Report Number2939274-2018-53066
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.033.070S
Device Catalogue Number04.033.070S
Device Lot NumberL828180
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 Received08/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2018
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: 07/24/2018 Patient Sequence Number: 1
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