MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 34MM; SCREW, FIXATION, BONE

Model Number	201.687
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Foreign Body In Patient (2687); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Part was not explanted, still retained in the patient.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 or Problem Description
It was reported on (b)(6) 2018, the patient underwent a hardware removal procedure due to wound break down.There are four (4) self tapping metaphyseal screws, four (4) variable angle (va) self tapping locking screws, one (1) va large locking calcaneal plate, and one (1) self tapping cortex screw were removed.One (1) self tapping cortex screw remained implanted due to unknown reason.Originally, the hardware was implanted on (b)(6) 2018.The procedure was completed successfully.Patient status or surgical delay is unknown.This complaint involves eleven (11) device.The other parts associated with this complaint are located in (b)(4).This report is 1 of 1 for (b)(4).

• Brand Name: 2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 34MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7897978
• Report Number: 2939274-2018-53901
• Device Sequence Number: 1433814
• Product Code: HWC
• UDI-Device Identifier: 10886982142535
• UDI-Public: (01)10886982142535
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 201.687
• Device Catalogue Number: 201.687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 79