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

Model Number	04.038.395S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exp date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 an unknown date, the trochanteric fixation nail advanced (tfna) blade experienced a cutout for an intertrochanteric fracture.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.
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.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
Concomitant devices reported: titanium cannulated tfna nail (part#04.037.042s, lot#unknown, quantity 1); titanium locking screw stardriver (part#04.005.524s, lot#unknown, quantity unknown);.

• Brand Name: TFNA FENESTRATED 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: 8575155
• Report Number: 2939274-2019-57796
• Device Sequence Number: 2073177
• Product Code: HSB
• UDI-Device Identifier: 10886982099273
• UDI-Public: (01)10886982099273
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 04.038.395S
• Device Catalogue Number: 04.038.395S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/31/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention