MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.162S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture additional medical/surgical intervention required.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.
Event or Problem Description
It was reported that on (b)(6) 2018, patient underwent a femoral fracture procedure.During the procedure, a helical blade completely missed the nail.There was a surgical delay of about one and a half hour to get the nail out and the surgeon had to re-do the procedure using a smaller diameter nail and a new blade.The procedure was completed successfully with no impact to the patient.Patient outcome was reported as fine.This report is for one (1) 11mm/130 deg ti cann tfna 420mm/right - sterile.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 22-sep-2017.Expiration date: 31-aug-2027.Part #: 04.037.162s, lot#: h458299 (sterile) - 11mm/130 deg ti cann tfna 420mm / right - sterile.Quantity 6.Inspection sheet for tfna assembly inspection and inspection sheet for in-process/inspect dimensional/final met inspection acceptance criteria.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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.

• Brand Name: 11MM/130 DEG TI CANN TFNA 420MM/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: 7508651
• Report Number: 2939274-2018-52153
• Device Sequence Number: 1529757
• Product Code: HSB
• UDI-Device Identifier: 10886982096708
• UDI-Public: (01)10886982096708
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: 04.037.162S
• Device Catalogue Number: 04.037.162S
• Device Lot Number: H458299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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