MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 235/RIGHT - SILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.044S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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) 2021, the surgeon had locked the proximal locking interlocking mechanism in the trochanteric fixation nail advanced (tfna).The tfna system, short nail, locked its interlocking mechanism to the unknown blade in the unknown screw.The surgeon wants to insert the proximal blade or screw option and the interlocking mechanism which was not allowing the screw blade to engaged.The surgeon had tightened the interlock before putting it on the insertion handle.Then, when putting in the proximal blade, and had issues because the locking mechanism was already down.It was in the patient when the nail was improperly engaged, but it was removed and got a new nail.There was no patient harm.The procedure was successfully completed without a surgical delay.Concomitant device reported.Unknown insertion handle.This complaint involves three (3) devices.This report is for (1) 10/130 deg ti cann tfna 235/right - sile.This report is 1 of 3 for (b)(4).

• Brand Name: 10/130 DEG TI CANN TFNA 235/RIGHT - SILE
• 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: 12249166
• Report Number: 2939274-2021-04321
• Device Sequence Number: 2795921
• Product Code: HSB
• UDI-Device Identifier: 10886982096005
• UDI-Public: (01)10886982096005
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 04.037.044S
• Device Catalogue Number: 04.037.044S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAIL INSERTION HANDLES; UNK - SCREWS: TRAUMA
• Patient Weight: 60