MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 32MM; SCREW, FIXATION, BONE

Model Number 02.211.032

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.Additional product code: hrs.Exp.Date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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 a patient underwent a hardware removal surgery due to wound breakdown on (b)(6) 2018.Four (4) self tapping metaphyseal screws, four (4) variable angle (va) self tapping locking screws, one (1) va large locking calcaneal plate, one (1) self tapping cortex screw were removed.One (1) self tapping cortex screw remained implanted due to unknown reason.Original implant date is on (b)(6) 2018.Patient status is unknown.The procedure was completed successfully.This report is 10 of 10 for (b)(4).This complaint involves ten (10) devices.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 32MM
• 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 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7891878
• MDR Text Key: 120823941
• Report Number: 2939274-2018-53879
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982053671
• UDI-Public: (01)10886982053671
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.211.032
• Device Catalogue Number: 02.211.032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 79