MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP T-PLATE 3H HEAD/ 7H SHAFT/87MM-RIGHT ANGLE; APPLIANCE,FIXATION,NAIL

Model Number	241.171
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight was not provided for reporting.Date of initial implant and therapy date of concomitant device is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed since the provided lot number is not valid.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 the patient underwent a revision of a left ankle fusion on (b)(6) 2017 due to the plate breaking post-operatively at the level where the head of the plate meets the shaft.The hardware failure was detected by x-ray on an unknown date.It is unknown if the patient had pain or discomfort related to the broken plate.The surgeon easily removed the broken plate and the plate fragments.Eight unknown 3.5mm cortex screws were removed whole and intact.One unknown 3.5mm cortex screw was broken, the head of the screw was removed but the screw fragment was retained because the surgeon did not think it needed to be retrieved.No surgical delay was reported.The new hardware implanted in the patient consist of a 4.5mm locking compression plate (lcp) anterior ankle arthrodesis plate and seven (7) screws, of which five were 4.5mm cortex screws and two were 6.5mm cancellous screws.The procedure was successfully completed.The patient outcome was reported stable.Concomitant devices reported: 3.5mm cortex screws (part# unknown, lot# unknown, quantity 8) this report is for one (1) 3.56mm lcp plate.This is report 1 of 2 for com-(b)(4).
Additional Manufacturer Narrative
Date of event is unknown.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: 3.5MM LCP T-PLATE 3H HEAD/ 7H SHAFT/87MM-RIGHT ANGLE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6682103
• Report Number: 3003506883-2017-10125
• Device Sequence Number: 16510135
• Product Code: KTT
• UDI-Device Identifier: 10886982166043
• UDI-Public: (01)10886982166043(10)5676324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: Physician
• Device Model Number: 241.171
• Device Catalogue Number: 241.171
• Device Lot Number: 5676324
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 07/31/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EIGHT (8) UNKNOWN 3.5MM CORTEX SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR