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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.015S
Device Problems Break (1069); Crack (1135)
Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2020. (b)(4). The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 (b)(6) 2020 the patient underwent revision surgery for one (1) tfna blade and one (1) tfna femoral nail due to pain. After removing the blade, the surgeon noticed the nail was cracked but not completely broken. However, during the removal process the nail completely fractured into two (2) pieces. The implant was initially inserted in (b)(6) 2020. There is no further information available. Concomitant devices reported: unknown tfna end cap (part# unknown, lot# unknown, quantity 1). Locking screw l44 f/nails tan light green (part# 04. 005. 534, lot# l761200, quantity 1). This report is for one (1) 10mm/125 deg ti cann tfna 235mm/left - sterile. This is report 1 of 2 for (b)(4).
 
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Brand Name10MM/125 DEG TI CANN TFNA 235MM/LEFT - 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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10514038
MDR Text Key206350217
Report Number2939274-2020-04020
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.015S
Device Lot NumberH612163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2018
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: 09/10/2020 Patient Sequence Number: 1
Treatment
LOCKSCR 5 L44 F/NAILS TAN LIGHT GREEN; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
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