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

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.

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 26MM
• Type of Device: SCREW,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 Key: 7361637
• MDR Text Key: 103174986
• Report Number: 2939274-2018-51165
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982154620
• UDI-Public: (01)10886982154620(10)LOT#UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• 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 Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214.826
• Device Catalogue Number: 214.826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR