MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® PROXIMAL FEMUR PLATE 10 HOLES/283MM-LEFT; PLATE, FIXATION, BONE

Model Number	242.110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity: this information is unknown.It is unknown when non-union occurred.Additional procode: hwc.Lot number is unknown.Date of implantation is unknown.Reporter facility is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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) 2018, the patient underwent revision of proximal femur plate due to pain non-union using gamma nail.Procedure was completed successfully with no reported delay.Patient outcome was stable.This report is for a 4.5 mm lcp® proximal femur plate 10 holes/283 mm-left.This is report 1 of 2 for (b)(4).

• Brand Name: 4.5MM LCP® PROXIMAL FEMUR PLATE 10 HOLES/283MM-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: 7650743
• Report Number: 2939274-2018-52682
• Device Sequence Number: 19436074
• Product Code: HRS
• UDI-Device Identifier: 10886982167989
• UDI-Public: (01)10886982167989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: 242.110
• Device Catalogue Number: 242.110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR