MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.056S
Medical Device Problem Codes	Failure to Align (2522); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth and weight were not provided for reporting.Device was implanted on (b)(6) 2018 and remained implanted.Device explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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) 2018, patient underwent surgery.During the surgery, while using the hip tfna nail, the surgeon went to take the locking mechanism of the nail down and it wouldn¿t budge.They were unable to see on the x-rays whether the nail was up or down, so they had to take the blade and nail out and put them back in again.This time, the locking mechanism moved without a problem.Due to this, twenty-five (25) minutes were added to the procedure.The procedure was completed successfully with no harm to the patient.Concomitant devices reported: helical blade (part# unknown, lot# unknown, quantity 1).This report is for one (1) 10mm/130 deg ti cann tfna 360mm/right ¿ sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - 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: 7440255
• Report Number: 2939274-2018-51806
• Device Sequence Number: 1095239
• Product Code: HSB
• UDI-Device Identifier: 10886982096128
• UDI-Public: (01)10886982096128
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2018

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: 04.037.056S
• Device Catalogue Number: 04.037.056S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1