MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.024S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2017, the trochanteric femoral nail advance (tfna) distal screw and tfna nail broke during an unknown procedure.A proposed removal procedure for a total hip arthroplasty is yet to be scheduled.There was an unknown surgical delay.Procedure and patient outcome are unknown.This report is for one (1) 10mm/125 deg ti cann tfna 340mm/right - sterile this is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Expiration date & lot number are unknown.Patient code 3191 used to capture: the reported event required medical/surgical intervention to preclude permanent damage to a body structure.Hospital & doctors information provided.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
01/16/2019.Updated event description: it was reported that the case was completed on (b)(6) 2017.The trochanteric femoral nail advance (tfna) lag screw and unknown distal locking screw broke in the tfna nail during an unknown procedure.A proposed removal procedure for a total hip arthroplasty is yet to be scheduled.There was an unknown surgical delay.Procedure and patient outcome was unknown.This complaint involved three (3) devices.This report is for one (1) 10mm/125 deg ti cann tfna 340mm/right - sterile.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The initial complaint was reviewed and found not reportable.Based on the information received from the sales consultant it was confirmed that only the lag screw and distal locking screw were broke and tfna nail is not broken.This was also confirmed with the mso by reviewing the x-rays attached in the complaint file.There is no report of an adverse event involving this synthes device.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: 10MM/125 DEG TI CANN TFNA 340MM/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: 8254067
• Report Number: 2939274-2019-55892
• Device Sequence Number: 16503792
• Product Code: HSB
• UDI-Device Identifier: 10886982095824
• UDI-Public: (01)10886982095824
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2018

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: 04.037.024S
• Device Catalogue Number: 04.037.024S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 02/06/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/04/2019; 02/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR