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

Model Number	04.038.185
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: ktt.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.
Event or Problem Description
It was reported that during an intramedullary (im) nailing of intertrochanteric fracture procedure on (b)(6) 2020, the trochanteric fixation nail advanced (tfna) fenestrated screw got stuck in the tfna nail and could not be advanced or pulled back.The nail was able to be removed and exchanged with another nail.A second tfna set was used to proceed with the case.It is unknown if there was a surgical delay.Patient status and surgical outcome were unknown.Concomitant device reported: tfna screw inserter (part # 03.037.025 lot # l503499, quantity 1), connecting screw for tfna helical blade and screw (part # 03.037.026 lot # l987541, quantity 1), extraction instrument for tfna helical blade and screw (part # 03.037.030, lot # 534061, quantity 1); 11mm/125 deg ti cann tfna 235mm/left, sterile (part # 04.037.115s, lot # 49p4912, quantity 1).This report is for one (1) tfna fenestrated screw 85mm.This is report 1 of 2 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 85MM
• 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: 10621557
• Report Number: 2939274-2020-04467
• Device Sequence Number: 2604311
• Product Code: HSB
• UDI-Device Identifier: 10886982098702
• UDI-Public: (01)10886982098702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 04.038.185
• Device Catalogue Number: 04.038.185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/02/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE; HELICAL BLADE/SCREW COUPLING SCREW; HELICAL BLADE/SCREW EXTRACTOR; SCREW INSERTER