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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 300MM/RIGHT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 300MM/RIGHT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.450S
Device Problem Break (1069)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)
Event Date 01/29/2022
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient¿s nail broke post-op, which caused the patient to experience increased pain, infection, non-union, allergic reaction, osteoporosis, overloading, degenerative diseases, and bleeding. On (b)(6) 2022, the nail was removed. This report involves (1) 14mm/130 deg ti cann tfna 300mm/right-sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name14MM/130 DEG TI CANN TFNA 300MM/RIGHT-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13523388
MDR Text Key285546290
Report Number2939274-2022-00465
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.450S
Device Lot NumberH060283
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2016
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/14/2022 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
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