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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 26MM SCREW,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 26MM SCREW,FIXATION,BONE Back to Search Results
Model Number 214.826
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Additional narrative: (b)(6). Patient weight was not provided for reporting. Date of event is unknown. (b)(4). Date of implant is unknown. Date of event was reported as (b)(6) 2018. It is unknown if this date represents date of revision/explant. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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 an unknown date, patient underwent initial open reduction and internal fixation (orif) humeral shaft surgery and the patient was implanted with a plate and seven (7) screws. Patient underwent revision of orif humeral shaft due to loosening of the proximal screws from the plate causing a nonunion of the fracture. During the revision, the plate and screws were removed, and a humeral nail and three (3) locking screws were implanted to stabilize the fracture. Concomitant device reported: 4. 5mm narrow lcp® plate 10 holes/188mm (part# 224. 601, lot# unknown, quantity 1). This report is for one (1) 4. 5mm cortex screw self-tapping 26mm. (b)(4).

 
Manufacturer Narrative

Patient code (b)(4) used in the initial report to capture additional medical/surgical intervention required. 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.

 
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Brand Name4.5MM CORTEX SCREW SELF-TAPPING 26MM
Type of DeviceSCREW,FIXATION,BONE
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7361637
MDR Text Key103174986
Report Number2939274-2018-51165
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112583
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number214.826
Device Catalogue Number214.826
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 Received03/22/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/22/2018 Patient Sequence Number: 1
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