MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.158S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier is unknown.It is unknown when device broke.Lot number is unknown.Date of implantation is unknown.Date of explantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 patient underwent removal of a trochanteric fixation nail advanced (tfna) nail due to a broken tfna nail as well as non-union.The nail was broken at the lag screw junction.Procedure outcome and patient status are unknown.Concomitant devices: tfna fenestrated screw 100mm ¿ sterile (part: 04.038.200s, lot: unknown, quantity: 1).This report is for a 11mm/130 degree titanium (ti) cannulated tfna 380mm/right ¿ 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.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
The procedure was completed successfully.Patient was fine following surgery.

• Brand Name: 11MM/130 DEG TI CANN TFNA 380MM/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: 7842086
• Report Number: 2939274-2018-53584
• Device Sequence Number: 1129836
• Product Code: HSB
• UDI-Device Identifier: 10886982096661
• UDI-Public: (01)10886982096661
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 04.037.158S
• Device Catalogue Number: 04.037.158S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/04/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: UNKNOWN; THERAPY DATE: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 91