MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA-LCP LAT ANT CLAV PL/9 HOLE/89; PLATE, FIXATION, BONE

Model Number	02.112.046
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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
It was reported that on an unknown date, the patient underwent a fracture fixation for a shaft fracture utilizing variable angle locking compression plate (va-lcp) anterior plate.Postoperatively the patient suffered a refracture.A revision open reduction internal fixation (orif) procedure was completed without refracture.It was noted the reoperation was done due to broken/bent plate and refracture.Union was achieved after six (6) weeks.Patient outcome is unknown.This report is for a va-lcp anterior plate.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7/3.5 VA-LCP LAT ANT CLAV PL/9 HOLE/89
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12460559
• Report Number: 2939274-2021-05354
• Device Sequence Number: 1180111
• Product Code: HRS
• UDI-Device Identifier: 10886982033017
• UDI-Public: (01)10886982033017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.112.046
• Device Catalogue Number: 02.112.046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR