MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM LCP(TM) PLATE 6 HOLES 52MM; PLATE, FIXATION, BONE

Model Number	249.676
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2020.Date of implantation is an unknown date in 2020.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.(b)(4).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) 2020, patient underwent an orthopedic procedure and a hardware removal due to nonunion.Patient returned to surgery for removal of hardware status post corrective surgery to ulna shaft.Patient presents with a nonunion of osteotomy.This report is for a 2.4mm locking compression plate (lcp) plate, this is report 1 of 5 for (b)(4).

• Brand Name: 2.4MM LCP(TM) PLATE 6 HOLES 52MM
• 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: 10474024
• Report Number: 2939274-2020-03874
• Device Sequence Number: 2391640
• Product Code: HRS
• UDI-Device Identifier: 10886982171221
• UDI-Public: (01)10886982171221
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: 249.676
• Device Catalogue Number: 249.676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR