MAUDE Adverse Event Report: SYNTHES GRENCHEN TI DISTAL FEMUR LISS PLATE 13 HOLES/316MM-LEFT; PLATE,FIXATION,BONE

Catalog Number	422.349
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient height reported as 5¿8¿.(b)(6).Additional product codes: jds, hwc.Date of implant reported as (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4).Manufacturing date: 13.Mar.2013.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 a hardware removal was performed for an infected non-union of the left metaphyseal-diaphyseal area of a distal femur on (b)(6) 2017.The date of the original procedure was five months ago in (b)(6) 2017, at which time the patient suffered polytrauma.Subsequently, it is unknown when the infected non-union was identified and there is no information regarding patient symptoms.Removed hardware included: one (1) less invasive stabilization system (liss) distal femur plate (intact) and eleven (11) 5.0mm titanium locking screws of various sizes.It was reported that the surgical team had to drill the head out of some (exact quantity unknown) of the 5.0mm locking screws due to the screw heads getting cold-welded to the plate.Nothing unexpectedly occurred during the removal procedure.The removal procedure was completed successfully with the patient in stable condition.Revision surgery due to mal-union/infection is addressed in (b)(4).This report addresses the intraoperative issue with the locking screws.This report is for one (1) distal femur liss plate.This is report 1 of 2 for (b)(4).

• Brand Name: TI DISTAL FEMUR LISS PLATE 13 HOLES/316MM-LEFT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• MDR Report Key: 6673098
• Report Number: 3009450884-2017-10087
• Device Sequence Number: 46035
• Product Code: HRS
• UDI-Device Identifier: 10886982215819
• UDI-Public: (01)10886982215819(10)8337137
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K962047
• 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
• Report Date (Section B): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 422.349
• Device Lot Number: 8337137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/28/2017
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 71