MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 LCP PROXIMAL FEMUR PL 8H/247/RT-S; PLATE,FIXATION,BONE

Model Number 242.808S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date of event: event year is reported as 2021; however exact date of event is unknown.Additional product code: hwc.Without a lot number, the device history records review could not be completed as no product was received.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 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 Description

It was reported that on an unknown date, during a removal procedure, the plate was removed due to bone healing failure.This was implanted no (b)(6) 2021.Patient outcome is unknown.This complaint involves ten (10) devices.This report is for (1) 4.5 lcp proximal femur pl 8h/247/rt-s.This report is 6 of 10 for (b)(4).

• Brand Name: 4.5 LCP PROXIMAL FEMUR PL 8H/247/RT-S
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12502450
• MDR Text Key: 272541934
• Report Number: 2939274-2021-05607
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982168870
• UDI-Public: (01)10886982168870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2021

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
• Device Operator: Health Professional
• Device Model Number: 242.808S
• Device Catalogue Number: 242.808S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention