MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.256S

Device Problems Entrapment of Device (1212); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn.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.

Event Description

It was reported that on (b)(6) 2018, during a trochanteric fixation nail advanced (tfna) hip surgery, the surgeon presented an x-ray image on (b)(6) 2018, that showed, that the lag screw had collapsed into the nail.This is an intended design of the tfna, however, the surgeon has the option to lack the lag screw in a rigid construct, this was the procedure that was applied.The intention was to hold the reduction in a static position, however, the lag screw collapsed into the nail and it remained in the patient.Patient status is unknown.There was no surgical delay.Procedure was completed successfully.This report is for one (1) 1tfna screw 105mm.This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

Event Description

It was reported patient underwent a trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2018.Surgeon opted to use the static method and locked the lag screw, creating a rigid construct.Surgery was completed successfully.X-ray taken on (b)(6) 2018 revealed the lag screw had migrated into the nail.The devices remain implanted, no revision procedure is planned.

Manufacturer Narrative

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.(b)(6).Date reported in initial medwatch was 10/18/2018.Correct date should have been 10/17/2018.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.

Manufacturer Narrative

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

The x-ray was taken on (b)(6) 2018 and shown to the sales consultant on (b)(6) 2018.The lag screw had collapsed into the nail.This is an intended design of the tfna, however the surgeon has the option to lack the lag screw in a rigid construct which he did.His intention was to hold the reduction in a static position; instead the lag screw collapsed into the nail.

• Brand Name: TFNA SCREW 105MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8043304
• MDR Text Key: 126293369
• Report Number: 2939274-2018-54865
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097361
• UDI-Public: (01)10886982097361
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.256S
• Device Catalogue Number: 04.038.105S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR