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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 115MM ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 115MM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.215
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Additional procode: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 history lot: part number: 04. 038. 215-us, lot number: 11l8641, part manufacture date: jul 12, 2019, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of tfna fenestrated screw 115mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. Device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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, the patient underwent revision surgery for proximal femur fracture due to malunion/nonunion. Tfna was removed and a smith and nephew nail was then implanted in place along with a 4. 5mm proximal femur hook plate. The date of the original implant was unknown. There was no surgical delay reported. The procedure was successfully completed. This report is for one (1) tfna fenestrated screw 115mm. This is report 3 of 4 for (b)(4).
 
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Brand NameTFNA FENESTRATED SCREW 115MM
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)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10905732
MDR Text Key218913824
Report Number2939274-2020-05319
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
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 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.038.215
Device Catalogue Number04.038.215
Device Lot Number11L8641
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 Received11/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2019
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: 11/25/2020 Patient Sequence Number: 1
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