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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 7891878
• Report Number: 2939274-2018-53879
• Device Sequence Number: 1940198
• Product Code: HWC
• UDI-Device Identifier: 10886982053671
• UDI-Public: (01)10886982053671
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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: 02.211.032
• Device Catalogue Number: 02.211.032
• 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: 09/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 79