MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: DHHS HELIX BLADE; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number UNK - NAIL HEAD ELEM:DHHS HELI

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown dhhs helix blade/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 Description

It was reported that during an unknown procedure on an unknown date, the dynamic helical hip system (dhhs) helix blade didn¿t fully complete its rotation into the femoral head.The surgeon was still able to install the dhhs plate and inserted the screws in the shaft of the plate.Procedure outcome and patient status are unknown.Concomitant devices: dhhs plate (part: unknown, lot: unknown, quantity: 1), helix blade inserter (part: unknown, lot: unknown, quantity: 1).This report is for an unknown dhhs helix blade.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: DHHS HELIX BLADE
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10322092
• MDR Text Key: 200320181
• Report Number: 2939274-2020-03298
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - NAIL HEAD ELEM:DHHS HELI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/24/2020
• 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: UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - PLATES: DHHS