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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 105MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.205S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Unspecified Tissue Injury (4559)
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 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) 2021 patient underwent a hardware removal and total hip surgery due to non-union. The patient had a trochanteric fixation nail advanced (tfna) done in (b)(6) 2020. The patient voiced to surgeon that his previous surgeon stated it was a hardware failure and that is why he failed to heal. The surgeon doing surgery on (b)(6) 2021 stated it was not a hardware failure and it was because of his bone. This report is for one (1) tfna fenestrated screw 105mm - sterile. This is report 2 of 3 for (b)(4).
 
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Brand NameTFNA FENESTRATED SCREW 105MM - 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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11475398
MDR Text Key249244083
Report Number2939274-2021-01301
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 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.038.205S
Device Catalogue Number04.038.205S
Device Lot NumberH739928
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 Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2018
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: 03/12/2021 Patient Sequence Number: 1
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