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

Model Number	04.038.085S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pain (1994); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 or Problem Description
It was reported that on (b)(6) 2019, the patient underwent removal of hardware which was an intramedullary nail and screw fixator because of increasing pain with feelings of leg shortening and had a broken left intertrochanteric femoral nail.On (b)(6) 2018, the patient underwent intramedullary nail fixation of left intertrochanteric femur fracture with closed reduction and casting of left distal radius fracture.She presented with a left intertrochanteric femur fracture with left multisegmental distal radius fracture.On (b)(6) 2019, the patient underwent removal of hardware.The portion of the trochanteric fixation nail 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.Concomitant device reported: 5.0mm ti locking screw (part# 04.005.524s; lot number# unknown: quantity: 1).

• Brand Name: TFNA SCREW 85MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8928230
• Report Number: 2939274-2019-60078
• Device Sequence Number: 2207026
• Product Code: HSB
• UDI-Device Identifier: 10886982098450
• UDI-Public: (01)10886982098450
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.085S
• Device Catalogue Number: 04.038.085S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/23/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCK SCW WT25 STARDR 34MM NAIL-STER
• Outcome Attributed to Adverse Event: Required Intervention