MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG DHS PL-SHORT BARREL 4 HOLES/78; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number 281.504

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, patient underwent a removal of hardware and revision of open reduction internal fixation(orif) left femur due to failed fixation.Left hip, failed dhs construct for subtroch proximal femur fracture.The original surgery was on (b)(6) 2021.This report is for one (1) 130 deg dhs pl-short barrel 4 holes/78.This is report 1 of 7 for (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.(b)(4).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.

• Brand Name: 130 DEG DHS PL-SHORT BARREL 4 HOLES/78
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12902352
• MDR Text Key: 281500122
• Report Number: 2939274-2021-06865
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 10886982177483
• UDI-Public: (01)10886982177483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 281.504
• Device Catalogue Number: 281.504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1.7MM CABLE WITH CRIMP 750MM-STERILE; 1.7MM CABLE WITH CRIMP 750MM-STERILE; 4.5MM CORTEX SCREW SELF-TAPPING 36MM; 4.5MM CORTEX SCREW SELF-TAPPING 36MM; 4.5MM CORTEX SCREW SELF-TAPPING 38MM; 4.5MM CORTEX SCREW SELF-TAPPING 38MM; DHS/DCS LAG SCREW 12.7MM THREAD/90MM
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 75 KG