MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.944S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Device not implanted or explanted.(b)(4).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.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, during hip surgery, the sales consultant (sc) passed off the wrong degree of the trochanteric fixation nail advanced (tfna) to the field.The surgeon asked for a 125 but a 130 nail was passed by him.The blade would not enter into the head of the patient and began to run through possible scenarios.Sc checked the box in the trash and it was a 130 nail.The nail was removed, and the correct nail was passed to the field.There was a surgical delay of ten (10) minutes and then proceeded.This report is for one (1) 9mm/130 deg ti cann tfna 235mm/right-sterile.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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: 9MM/130 DEG TI CANN TFNA 235MM/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: 8121851
• Report Number: 2939274-2018-55218
• Device Sequence Number: 11205149
• Product Code: HSB
• UDI-Device Identifier: 10886982098047
• UDI-Public: (01)10886982098047
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.037.944S
• Device Catalogue Number: 04.037.944S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention