MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 95MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.295S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Impaired Healing (2378)
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.A review of the device history records has been requested.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 a patient underwent a hip surgery on an unknown date.A fracture displaced after the proximal femoral nailing system tfn-advanced (tfna) helical blade slide mechanism resulted in a migration effect.Surgical and patient outcome are unknown.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity unknown); unknown tfna nail (part# unknown, lot# unknown, quantity unknown).This report is for one (1) tfna helical blade 95mm sterile.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated event description.Device was used for treatment, not diagnosis.
Event or Problem Description
11/21/2018 updated event description: it was reported that a patient underwent a hip surgery on an unknown date.A fracture displaced after a proximal femoral nailing system tfn-advanced (tfna), a helical blade slide mechanism resulted in a windshield wiper effect, which means, the fracture collapsed and went into various and the blade migrates superiorly.Surgical delay is unknown.Surgical procedure and patient outcome is unknown.

• Brand Name: TFNA HELICAL BLADE 95MM 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: 8071072
• Report Number: 2939274-2018-54977
• Device Sequence Number: 11152512
• Product Code: HSB
• UDI-Device Identifier: 10886982099013
• UDI-Public: (01)10886982099013
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 04.038.295S
• Device Catalogue Number: 04.038.295S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention