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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 340MM / RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 340MM / RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.033.064S
Device Problem Use of Device Problem (1670)
Patient Problems Injury (2348); Not Applicable (3189)
Event Date 04/08/2020
Event Type  Injury  
Manufacturer Narrative
The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Device history lot: part number: 04. 033. 064s, synthes lot number: l945713, manufacturing site: (b)(4), release to warehouse date: july 05, 2018, expiry date: april 30, 2028. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. 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) 2020, during a femoral recon nailing of 1/3 shaft fractured femur on the patient, the right titanium cannulated femoral recon nail was becoming incarcerated within the femoral shaft. The surgeon had to reamed up to 12mm for the insertion of the 10mm nail. Upon removal of the incarcerated nail, there was femoral neck fracture. After the removal of the 10mm nail, a 9mm nail was inserted, and the femoral neck fracture was reduced and fixated with 6. 5 cannulated screws. The surgeon had to ream to 14. 5mm in order to insert the 9mm nail. The surgeon complaint that the proximal portion of the nail was too wide in diameter, therefore resulting in the incarnation due to the long or wide proximal taper of the femoral recon nail. The medical intervention required since, they had to change tables to insert 6. 5 cannulated screws into the femoral neck after the insertion of the 9mm nail and extra x-rays were needed. There was a surgical delay approximately of one hour and sixty (60) minutes. Procedure successfully completed. Patient status is good. Concomitant devices reported: unknown reamer (part # unknown, lot # unknown, quantity # 1). This complaint involves one (1) device. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM / TI CANN FRN / GT 340MM / 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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10002256
MDR Text Key189898946
Report Number2939274-2020-02052
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
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.033.064S
Device Catalogue Number04.033.064S
Device Lot NumberL945713
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 Received05/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/27/2020 Patient Sequence Number: 1
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