MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA-LCP MED DSTL TIBIA PL/10 H/RT; ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE

Model Number	02.118.008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product was not returned.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 additional information is made available, the investigation will be updated as applicable.A manufacturing record evaluation was performed for product code 02.118.008 on finished device lot number 5l66976; and no non-conformances were identified.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 or Problem Description
This is report 1 of 14 for (b)(4).It was reported by the sales rep that postoperatively to an unknown surgery performed on an unknown date, the patient had a removal of hardware procedure on (b)(6) 2022 due to non union and infection.According to the report, the patient was non-compliant that he would scratch the surgical site regularly causing the infection.It was further reported that the implants were removed and an ex fix was placed.The status of the patient post-removal of all hardware was unknown.No additional information was provided.This report is for one (1) 2.7/3.5 va-lcp med dstl tibia pl/10 h/rt device.This complaint involves 14 devices.

• Brand Name: 2.7/3.5 VA-LCP MED DSTL TIBIA PL/10 H/RT
• Common Device Name: ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14167132
• Report Number: 2939274-2022-01415
• Device Sequence Number: 5742115
• Product Code: HRS
• UDI-Device Identifier: 10886982037701
• UDI-Public: 10886982037701
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 02.118.008
• Device Catalogue Number: 02.118.008
• Device Lot Number: 5L66976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 86 KG