MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/135 DEG TI CANN TFNA 420MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.193S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event reported as (b)(6) 2018, however exact date is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).
Event or Problem Description
This report is against user facility medwatch number (b)(4), a copy is attached.The only information contained in this report is correction or additional information.It was reported that during removal of intramedullary fixation of the left hip at around (b)(6) 2018, the titanium cannulated proximal femoral nailing system (tfna) got broken.The hardware was originally implanted at around the month of (b)(6) 2017.It is unknown if there was surgical delay.Procedure and patient outcome is unknown.Concomitant devices reported: tfna screws (part # unknown, lot# unknown, quantity unknown).This report is for one (1) 11mm/135 deg ti cann tfna nail.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 11MM/135 DEG TI CANN TFNA 420MM/LEFT - 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: 7992852
• Report Number: 2939274-2018-54532
• Device Sequence Number: 1214137
• Product Code: HSB
• UDI-Device Identifier: 10886982096951
• UDI-Public: (01)10886982096951
• Combination Product (Y/N): N
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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: 04.037.193S
• Device Catalogue Number: 04037193S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention