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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
Initial reporter is synthes representative. This report is for an unknown constructs: expert femoral nail /unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. 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) 2016, a patient underwent a bilateral hardware removal of unknown expert tibial nail, locking compression plate (lcp) distal tibial plate, expert a2fn nail, and screws due to increased pain with swelling. While removing the implants, the healthcare providers located a cyst type body in the patient¿s right leg that was sent for culture, and the result revealed positive for infection. On or around (b)(6) 2015, the patient underwent an open reduction and internal fixation (orif) of the right tibial shaft and was implanted with an unknown lcp distal tibial plate, unknown expert a2fn nail and unknown screws. The patient was also implanted with an unknown expert tibial nail and unknown screws in the left tibial shaft. The implants were implanted due to a sustained right and left tibia shaft fractures. On or about (b)(6) 2016, the patient experienced significant pain in the left tibia that began to increase with swelling, and a swollen and painful right tibia while he was in a church. The patient sought medical attention early in (b)(6) 2016 and the healthcare providers found a fracture of an interlocking screw on an x-ray result but suggested to wait for a revision surgery in the event the symptoms would resolve on their own. The symptoms did not resolve on their own and the patient continued to seek medical care. The patient underwent a revision surgery in november 2017 and was implanted with an unknown device. This report is for one (1) constructs: expert femoral nail. This is report 3 of 5 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8439984
MDR Text Key139444879
Report Number2939274-2019-57066
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/21/2019 Patient Sequence Number: 1
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