MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) CONDYLAR PLATE; PLATE, FIXATION, BONE

Model Number	249.684
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(6).Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j sales representative.The investigation could not be completed, no product was received; 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 # 249.684.Lot # 9775842.Release to warehouse date: dec 17, 2015 manufacturer: mezzovico no ncr's were generated during production.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 the patient underwent a removal surgery of 2.7mm lcp l-plates, oblique left, 2 holes and unknown screws due to non-union on (b)(6) 2021.There was bone loss at the fracture side.The initial operation was a grossly open firework injury with fractures to the distal radius on (b)(6) 2020.A new 2.7 condylar plate was placed, and iliac crest bone graft was harvested and utilized.Procedure outcome is unknown.No patient consequences.This complaint involves eight (8) devices.This report is for (1) 2.7mm lcp(tm) condylar plate.This report is 1 of 8 for (b)(4).

• Brand Name: 2.7MM LCP(TM) CONDYLAR PLATE
• 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: 12028419
• Report Number: 2939274-2021-03060
• Device Sequence Number: 4354187
• Product Code: HRS
• UDI-Device Identifier: 10886982171290
• UDI-Public: (01)10886982171290
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• 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): 05/26/2021

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: 249.684
• Device Catalogue Number: 249.684
• Device Lot Number: 9775842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR
• Patient Weight: 37