MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM; PLATE,FIXATION,BONE

Model Number	02.112.527
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Unspecified Tissue Injury (4559)
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.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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: part # 02.112.527, synthes lot # 7791417, supplier lot # 7791417, release to warehouse date: sep 11, 2014, manufactured by synthes (b)(4).No ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 patient underwent removal medial distal tibia plate due to nonunion and skin breakdown.It is unknown if there was a surgical delay.Procedure outcome is unknown.This complaint involves fourteen (14) devices.This report is for (1) 3.5mm lcp low bend medial dstl tibia plate/12h/left/213mm.This report is 1 of 14 for (b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM
• 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: 12303554
• Report Number: 2939274-2021-04566
• Device Sequence Number: 11908587
• Product Code: HRS
• UDI-Device Identifier: 10886982034656
• UDI-Public: (01)10886982034656
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 02.112.527
• Device Catalogue Number: 02.112.527
• Device Lot Number: 7791417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 4.0 MM CANCELLOUS; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention