MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY

Model Number 04.038.085S

Device Problem Break (1069)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes legal professional. 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)(4). 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 (b)(6) 2019, the patient underwent removal of an intramedullary nail and screw fixator because of increasing pain with feelings of leg shortening as well as a broken left intertrochanteric femoral nail. The portion of the trochanteric fixation nail (tfna) was removed as well as the proximal screw. The distal screw was backed up to allow for passing of the extraction hook once this has been passed to. The nail was removed and then the distal portion of the nail was removed without issue. Once this had been accomplished and arthrotomy was made as well as removal of heterotropic ossification around the greater trochanter to facilitate removal of the next segment once the neck segment had been removed. Another stem was implanted in the patient. On or about (b)(6) 2018, the patient underwent intramedullary nail fixation of the left intertrochanteric femur fracture with closed reduction and casting of left distal radius fracture. Patient presented with a left intertrochanteric femur fracture with left multisegmental distal radius fracture. This report is for a tfna screw 85mm - sterile. This is report 2 of 2 for (b)(4).

• Brand Name: TFNA SCREW 85MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8928230
• MDR Text Key: 156289346
• Report Number: 2939274-2019-60078
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.038.085S
• Device Catalogue Number: 04.038.085S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/23/2019 Patient Sequence Number: 1