MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.165S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 was scheduled to undergo a replacement of 105mm helical blade but they noticed that the trochanteric fixation nail-advanced (tfna) was broken at the nail junction blade interface.Both the nail and helical blade were removed and replaced.There was no patient consequence reported.Surgical procedure delay and patient outcome is unknown.Concomitant devices reported: distal locking screw (part/lot unknown, quantity unknown); tfna blade (part 04.038.305s, lot unknown, quantity 1) this report is for a tfna nail.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(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 (b)(6) 2018, the patient was scheduled to undergo a replacement of 105mm helical blade due to discomfort in the patient.When the blade was removed, it was noticed the trochanteric fixation nail-advanced (tfna) was broken at the nail junction blade interface.Both the nail and helical blade were removed and replaced.There was no patient consequence reported.Surgical outcome is unknown.Concomitant devices: distal locking screw (part: unknown, lot: unknown, quantity: unknown), tfna blade (part: 04.038.305s, lot: unknown, quantity: 1).
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.

• Brand Name: 11MM/130 DEG TI CANN TFNA 440MM/LEFT - 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: 7930333
• Report Number: 2939274-2018-54119
• Device Sequence Number: 1448935
• Product Code: HSB
• UDI-Device Identifier: 10886982096739
• UDI-Public: (01)10886982096739
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2018

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: 04.037.165S
• Device Catalogue Number: 04.037.165S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 10/23/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/06/2018; 11/08/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR