MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/6H/117MM/LEFT; PLATE,FIXATION,BONE

Model Number	02.127.221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.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.Device history lot.Product code 02.127.221.Lot#: l120974.Manufacturing site: (b)(4).Release to warehouse date: sep.06, 2016.A manufacturing record evaluation was performed for the finished device lot number, 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
It was reported that on (b)(6) 2021 the surgeon was removing a plate and 9 screws from this patient.During the removal 3 of the 3.5mm screw heads broke off into the patient.These 3 screws remained in the patient.He also removed a plate and 6 screws all of which were removed successfully.Procedure was completed successfully.It is unknown if there were fragments generated.It is unknown if there were surgical delay and patient consequence.This complaint involves ten (10) devices.This report is for (1) 3.5mm va-lcp prox tibia plate small bend/6h/117mm/left.This is report 2 of 10 (b)(4).Related product complaint: (b)(4).

• Brand Name: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/6H/117MM/LEFT
• 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: 11273862
• Report Number: 2939274-2021-00651
• Device Sequence Number: 3494144
• Product Code: HRS
• UDI-Device Identifier: 10886982043528
• UDI-Public: (01)10886982043528
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 01/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.127.221
• Device Catalogue Number: 02.127.221
• Device Lot Number: L120974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4MM CRTX SCRW 3.5MM HEAD/SLF-TPNG 40MM; 3.5MM CORTEX SCREW SELF-TAPPING 40MM; 3.5MM CORTEX SCREW SELF-TAPPING 80MM; 3.5MM TI CORTEX SCREW SELF-TAPPING/80MM; 3.5MM TI CORTEX SCREW SELF-TAPPING/80MM; 3.5MM VBLE ANG LKNG SRW/SLF-TPN/STDRV/75MM; 3.5MM VBLE ANG LKNG SRW/SLF-TPN/STDRV/75MM; 3.5MM VBLE ANG LKNG SRW/SLF-TPN/STDRV/75MM; 3.5MM VBLE ANG LKNG SRW/SLF-TPN/STDRV/75MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR