MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 / TI CANN FRN / GT 360 / LEFT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.033.967S
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2022, during a routine frn nail insertion, the im nail got stuck in the canal of the femur.The canal 1.5mm reamed over the nail diameter and opened the proximal segment with the appropriate 14mm drill bit from the set.The nail became incarcerated upon insertion and the proximal body of the nail seemed to be too long for the proximal segment of the femur on this patient.The driving cap broke off leaving a fragment in the insertion handle due to incarceration that led the surgeon to have to strike the insertion handle to seat the nail.The surgeon determined that the nail was finally seated to a depth after a 30 min delay.Standard locking of the proximal and distal nail occurred without incident.This report is for one (1) 9 / ti cann frn / gt 360 / left - sile.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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: 9 / TI CANN FRN / GT 360 / LEFT - SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14254562
• Report Number: 2939274-2022-01570
• Device Sequence Number: 11970294
• Product Code: HSB
• UDI-Device Identifier: 10886982272331
• UDI-Public: (01)10886982272331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: 04.033.967S
• Device Catalogue Number: 04.033.967S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVING CAP/THREADED.; RADIOLUCENT INSERTION HANDLE FRN; UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL PROXIMAL LOCKING.
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 43 KG