MAUDE Adverse Event Report: SYNTHES TRAUMA: WRIGHTS LANE : SYNTHES USA PRODUC TFNA SCREW 75MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.075S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Concomitant devices reported: 9mm/125 deg ti cann tfna 340mm/right-sterile (part # 04.037.924s, lot # unknown, qty # 1) 5.0mm ti locking screw w/t25 stardrive 42mm for im nails (part # 04.005.532, lot # unknown, qty # product was not returned and without a lot number the device history records review could not be completed; the investigation could not be completed; no conclusion could be drawn.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 a trochanteric fixation nail advanced (tfna) hardware removal was performed on (b)(6) 2017 due to superior cut-out of the lag screw.The original right sided tfna procedure was performed on (b)(6) 2017.The nail, the lag screw and a distal locking screw were all removed intact.A total hip arthroplasty was performed after removal of the hardware.The procedure was successfully completed with no surgical delay.The patient was stable after the surgery.Concomitant devices reported: 9mm/125 deg ti cann tfna 340mm/right-sterile (part # 04.037.924s, lot # unknown, qty # 1) 5.0mm ti locking screw w/t25 stardrive 42mm for im nails (part # 04.005.532, lot # unknown, qty # 1) this complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: TFNA SCREW 75MM - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES TRAUMA: WRIGHTS LANE : SYNTHES USA PRODUC; 1302 wrights lane east; west chester 19380
• MDR Report Key: 7207470
• Report Number: 2939274-2018-50334
• Device Sequence Number: 16515476
• Product Code: HSB
• UDI-Device Identifier: 10886982098412
• UDI-Public: (01)10886982098412(17)UNKNNOWN(10)UNKNOWNLOTNUMBER
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

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: 04.038.075S
• Device Catalogue Number: 04.038.075S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR