MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM; PLATE, FIXATION, BONE

Model Number	241.361
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Add'l patient identifier: (b)(6).Implanted several years ago; exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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.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 a patient underwent a hardware removal due to pain on (b)(6) 2018.The hardware removed were one (1) malleolar screw, five (5) cortex screws, two (2) cancellous screw and one (1) tubular plate.There was no surgical delay.Procedure was successfully completed.Patient outcome was unknown.This report is for one (1) lcp one third tubular plate.This is report 4 of 4 for complaint (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM
• 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: 8195383
• Report Number: 2939274-2018-55567
• Device Sequence Number: 267835
• Product Code: HRS
• UDI-Device Identifier: 10886982166876
• UDI-Public: (01)10886982166876
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• 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): 12/02/2018

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: 241.361
• Device Catalogue Number: 241.361
• Device Lot Number: 7645609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2018
• Initial Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 68