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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM TI MULTILOC SCREW LENGTH 50MM ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM TI MULTILOC SCREW LENGTH 50MM ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.019.050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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) 2019, the patient had hardware removal of one (1) multiloc humeral nail, one (1) multiloc screw length 50mm, one (1) multiloc screw length 42mm, one (1) multiloc screw length 48mm, one (1) multiloc screw length 40mm, one (1) titanium locking screw length 34mm, and one (1) titanium locking screw length 36mm due to shoulder pain and limited mobility of humerus. There were four part proximal humerus fracture fixed with the nail but the bone had gone on to die. The surgeon removed all the implants because the head just fell into various collapse and take the dead bony fragments. Initial surgery was done on (b)(6) 2018. It is unknown if there was a surgical delay. Procedure and patient outcome are unknown. This report is for one (1) 4. 5mm ti multiloc screw 50mm. This is report 2 of 7 for complaint (b)(4).
 
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Brand Name4.5MM TI MULTILOC SCREW LENGTH 50MM
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)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8621218
MDR Text Key145419167
Report Number2939274-2019-58161
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103002
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 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.019.050
Device Catalogue Number04.019.050
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 Received05/21/2019
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: 05/17/2019 Patient Sequence Number: 1
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