MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP PROX TIB PL LOW BEND 14 H/206/RT; PLATE,FIXATION,BONE

Model Number	02.124.220
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, patient underwent a hardware removal and revision surgery due to nonunion and a bent plate.The revision surgery was scheduled for later that day.Patient had a nonunion of a tibia plateau fracture.Original fracture was of the proximal tibia treated with a 3.5mm lcp proximal tibia plate and associated 3.5mm locking screws.The patient required a revision surgery due to pain and bowing of the tibia.The plate and all screws were removed.The fracture was properly reduced, and a tibia nail x was implanted.It was unknown if the revision surgery completed successfully.Patient experienced pain and deformity.This complaint involves ten(10) devices.This report is for (1) 3.5 lcp prox tib pl low bend 14 h/206/rt this report is 1 of 10 for (b)(4).

• Brand Name: 3.5 LCP PROX TIB PL LOW BEND 14 H/206/RT
• 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: 12477809
• Report Number: 2939274-2021-05449
• Device Sequence Number: 4082154
• Product Code: HRS
• UDI-Device Identifier: 10886982042651
• UDI-Public: (01)10886982042651
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K011978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 02.124.220
• Device Catalogue Number: 02.124.220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 36; 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 36; 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 38; 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 60; 3.5 LOCKING SCREW SLF-TPNG SD RECESS 70; 3.5 LOCKING SCREW SLF-TPNG SD RECESS 75; 3.5 LOCKING SCREW SLF-TPNG SD RECESS 75; 3.5 LOCKING SCREW SLF-TPNG SD RECESS 80; 3.5 LOCKING SCREW SLF-TPNG SD RECESS 80
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR