MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM TI LCP® PROXIMAL TIBIA PLATE 8 HOLES/133MM-LEFT; PLATE, FIXATION, BONE

Model Number	439.939
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id and date of birth were not provided for reporting.Initial implant procedure was in (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is an unknown date in (b)(6) 2017.(b)(4).Device history records review was completed for part# 439.939, lot# 7505343.Manufacturing location: (b)(4), manufacturing date: oct 29, 2013.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5 mm ti proximal tibia plates was processed through the normal manufacturing and inspection operations with no non-conformance noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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 the patient had a proximal tibial fracture repair in (b)(6) in (b)(6) 2017 when a plate and 7 saginal screws (non-synthes) were implanted.Her us doctor knew about the procedure and reviewed her x-rays (not available) when she returned to the us and noted the fracture did not hold the fixation.It was poorly reduced and poorly fixed/technique failure.On (b)(6) 2017, all hardware was removed intact (1-plate and 7 saginal head screws with varying lengths.The patient was revised with two plates and screws.There was no surgical delay.The procedure was successful and patient outcome was reported as fine.Concomitant devices reported: saginal head screw (quantity #7).This report is for one (1) 3.5 mm ti lcp proximal tibia plate.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Patient height is (b)(6)" and bmi (b)(6).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
4 plates and 18 screws were implanted during the first revision surgery on (b)(6) 2017.Second revision surgery was performed on (b)(6) 2017.

• Brand Name: 3.5MM TI LCP® PROXIMAL TIBIA PLATE 8 HOLES/133MM-LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6372793
• Report Number: 3003506883-2017-10029
• Device Sequence Number: 16288149
• Product Code: HRS
• UDI-Device Identifier: 10886982219206
• UDI-Public: (01)10886982219206(10)7505343
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030597
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: 439.939
• Device Catalogue Number: 439.939
• Device Lot Number: 7505343
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 10/17/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEVEN (7) UNKNOWN SAGINAL HEAD SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 82